EMDN Z11: Bioimaging and Radiotherapy Instruments
Complete hierarchy for EMDN group Z11 in category Z (Medical Equipment and Related Accessories, Software and Consumables): 308 terminal codes, EMDN v2026. Terminal codes are the ones accepted in a EUDAMED device record.
Registered classes, as of 8 Sep 2026. For each code with at least 20 registrations under a legislation, the chip shows how devices registered in EUDAMED under that code are classed, counted once per primary UDI-DI and kept separate for each legislation. It is not a determination. The class of a device comes from the MDR and IVDR classification rules for its intended purpose. MDD and IVDD classes are the directive classification and can differ from the class the same device would have under MDR or IVDR.
Z11Bioimaging and Radiotherapy InstrumentsZ1102Nuclear Medicine InstrumentsZ110201Computerised Gamma CamerasZ11020101Mobile Gamma CamerasterminalZ11020102Fixed Station Gamma Cameras with Single Head - without ‘total Body' AcquisitionterminalZ11020103Fixed Station Gamma Cameras with Single Head - with ‘total Body’ AcquisitionterminalZ11020104Fixed Station Gamma Cameras with Multiple Heads - without ‘total Body’ AcquisitionterminalZ11020105Fixed Station Gamma Cameras with Multiple Heads - with ‘total Body’ AcquisitionterminalZ11020180Computerised Gamma Cameras -Hardware AccessoriesterminalZ11020182Computerised Gamma Cameras - Software AccessoriesterminalZ11020185Computerised Gamma Cameras -ConsumablesterminalZ11020192Computerised Gamma Cameras - Medical Device Softwareterminal
Z110202Integrated Ct/Gamma Camera SystemsRegistered in EUDAMED under MDR with this code: 49 of 49 devices carry Class IIb on their registration (as of 8 Sep 2026).
- 49 Class IIb (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11020280Integrated Ct/Gamma Camera Systems - Hardware AccessoriesterminalZ11020282Integrated Ct/Gamma Camera Systems - Software AccessoriesterminalZ11020285Integrated Ct/Gamma Camera Systems - ConsumablesterminalZ11020292Integrated Ct/Gamma Camera Systems - Medical Device Softwareterminal
Z110203Integrated Ct/PET SystemsRegistered in EUDAMED under MDR with this code: 95 of 95 devices carry Class IIb on their registration (as of 8 Sep 2026).
- 95 Class IIb (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11020380Integrated Ct/PET Systems - Hardware AccessoriesterminalZ11020382Integrated Ct/PET Systems - Software AccessoriesterminalZ11020385Integrated Ct/PET Systems - ConsumablesterminalZ11020392Integrated Ct/PET Systems - Medical Device Softwareterminal
Z110204Positron Emission Tomography InstrumentsZ11020401Positron Emission TomographsterminalZ11020480Positron Emission Tomography Instruments - Hardware AccessoriesterminalZ11020482Positron Emission Tomography Instruments - Software AccessoriesterminalRegistered in EUDAMED under MDR with this code: 26 of 26 devices carry Class IIb on their registration (as of 8 Sep 2026).
- 26 Class IIb (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11020492Positron Emission Tomography Instruments - Medical Device Softwareterminal
Z110205Radioisotope ScannersterminalZ110206Intraoperative Radioisotope ScannersterminalZ110207Integrated MRI/PET SystemsZ11020701MRI/PET SystemsterminalRegistered in EUDAMED under MDR with this code, the 31 devices are split across classes (as of 8 Sep 2026).
- 29 Class I (93.5%)
- 2 Class IIa (6.4%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11020782Integrated MRI/PET Systems - Software AccessoriesterminalZ11020785Integrated MRI/PET Systems - ConsumablesterminalZ11020792Integrated MRI/PET Systems - Medical Device Softwareterminal
Z110290Various Instruments for Nuclear MedicineRegistered in EUDAMED under MDR with this code, the 61 devices are split across classes (as of 8 Sep 2026).
- 48 Class IIa (78.6%)
- 13 Class I (21.3%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11029002CyclotronsterminalZ11029003LymphoscintigraphsterminalZ11029004Radioactive Gas ProducersterminalRegistered in EUDAMED under MDR with this code: 32 of 33 devices carry Class I on their registration (as of 8 Sep 2026).
- 32 Class I (96.9%)
- 1 Class IIb (3.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11029080Various Instruments for Nuclear Medicine - Hardware AccessoriesterminalZ11029082Various Instruments for Nuclear Medicine - Software AccessoriesterminalZ11029085Various Instruments for Nuclear Medicine - ConsumablesterminalZ11029092Various Instruments for Nuclear Medicine - Medical Device SoftwareterminalRegistered in EUDAMED under MDR with this code: 253 of 257 devices carry Class I on their registration (as of 8 Sep 2026).
- 253 Class I (98.4%)
- 4 Class IIb (1.5%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z1101Radiotherapy and Radiosurgery InstrumentsZ110101Linear AcceleratorsZ11010101Single Energy Linear AcceleratorsterminalZ11010102Medium and Multi Energy Linear AcceleratorsterminalZ11010103Multi and High Energy Linear AcceleratorsterminalZ11010104Intra-Operative Linear AcceleratorsterminalRegistered in EUDAMED under MDR with this code, the 51 devices are split across classes (as of 8 Sep 2026).
- 27 Class IIb (52.9%)
- 24 Class I (47.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11010182Linear Accelerators - Software AccessoriesterminalZ11010185Linear Accelerators - ConsumablesterminalZ11010192Linear Accelerators - Medical Device SoftwareterminalRegistered in EUDAMED under MDR with this code, the 262 devices are split across classes (as of 8 Sep 2026).
- 242 Class I (92.3%)
- 10 Class IIa (3.8%)
- 10 Class IIb (3.8%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z110102Radiotherapy Simulation InstrumentsZ11010201Radiotherapy SimulatorsterminalZ11010202Computed Tomography (Ct) for Radiotherapy SimulationterminalZ11010280Instruments for Radiotherapy Simulation - Hardware AccessoriesterminalZ11010282Instruments for Radiotherapy Simulation - Software AccessoriesterminalZ11010285Instruments for Radiotherapy Simulation - ConsumablesterminalZ11010292Instruments for Radiotherapy Simulation - Medical Device Softwareterminal
Z110103Brachytherapy Radiation InstrumentsZ11010301Brachytherapy Radiation SystemsterminalZ11010380Brachytherapy Radiation Systems - Hardware AccessoriesMDR 2 classes · n=560MDD 95.8% Class IIa · n=170terminalRegistered in EUDAMED under MDR with this code, the 560 devices are split across classes (as of 8 Sep 2026).
- 305 Class IIa (54.4%)
- 255 Class I (45.5%)
Registered in EUDAMED under MDD with this code: 163 of 170 devices carry Class IIa on their registration (as of 8 Sep 2026).
- 163 Class IIa (95.8%)
- 7 Class I (4.1%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
Z11010382Brachytherapy Radiation Systems - Software AccessoriesterminalZ11010385Brachytherapy Radiation Systems - ConsumablesMDR 2 classes · n=85MDD 100.0% Class IIb · n=59terminalRegistered in EUDAMED under MDR with this code, the 85 devices are split across classes (as of 8 Sep 2026).
- 72 Class IIb (84.7%)
- 13 Class I (15.2%)
Registered in EUDAMED under MDD with this code: 59 of 59 devices carry Class IIb on their registration (as of 8 Sep 2026).
- 59 Class IIb (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
Z11010392Brachytherapy Radiation Systems - Medical Device Softwareterminal
Z110104Radiotherapy Treatment Planning InstrumentsZ11010401Radiotherapy Treatment Planning SystemsterminalZ11010480Radiotherapy Treatment Planning Instruments - Hardware AccessoriesMDR 100.0% Class I · n=48terminalRegistered in EUDAMED under MDR with this code: 48 of 48 devices carry Class I on their registration (as of 8 Sep 2026).
- 48 Class I (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11010482Radiotherapy Treatment Planning Instruments - Software AccessoriesterminalRegistered in EUDAMED under MDR with this code: 99 of 99 devices carry Class I on their registration (as of 8 Sep 2026).
- 99 Class I (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11010492Radiotherapy Treatment Planning Instruments - Medical Device Softwareterminal
Z110105Intravascular Radiotherapy InstrumentsZ11010501Intravascular Radiotherapy SystemsterminalZ11010580Intravascular Radiotherapy Instruments - Hardware AccessoriesterminalZ11010582Intravascular Radiotherapy Instruments - Software AccessoriesterminalZ11010585Intravascular Radiotherapy Instruments - ConsumablesterminalZ11010592Intravascular Radiotherapy Instruments - Medical Device Softwareterminal
Z110107Radiosurgery InstrumentsZ11010701Radiosurgery SystemsterminalZ11010780Radiosurgery Instruments - Hardware AccessoriesterminalZ11010782Radiosurgery Instruments - Software AccessoriesterminalZ11010785Radiosurgery Instruments - ConsumablesterminalZ11010792Radiosurgery Instruments - Medical Device Softwareterminal
Z110108Tomotherapy InstrumentsZ11010801Tomotherapy SystemsterminalZ11010880Tomotherapy Instruments - Hardware AccessoriesterminalZ11010882Tomotherapy Instruments - Software AccessoriesterminalZ11010885Tomotherapy Instruments - ConsumablesterminalZ11010892Tomotherapy Instruments - Medical Device Softwareterminal
Z110109Magnetic Resonance Radiotherapy InstrumentsZ11010901Integrated Systems for Magnetic Resonance RadiotherapyterminalZ11010980Magnetic Resonance Radiotherapy Instruments - Hardware AccessoriesterminalZ11010982Magnetic Resonance Radiotherapy Instruments - Software AccessoriesterminalZ11010985Magnetic Resonance Radiotherapy Instruments - Specific MaterialsterminalZ11010992Magnetic Resonance Radiotherapy Instruments - Medical Device Softwareterminal
Z110110Instruments for Proton TherapyZ11011001Proton Therapy SystemsterminalZ11011080Proton Therapy Instruments - Hardware AccessoriesterminalZ11011082Proton Therapy Instruments - Software AccessoriesterminalZ11011085Proton Therapy Instruments - ConsumablesterminalZ11011092Proton Therapy Instruments - Medical Device Softwareterminal
Z110190Various Radiotherapy and Radiosurgery InstrumentsZ11019004Automatic Curve TracersterminalZ11019005Shielding Block CuttersterminalZ11019080Various Radiotherapy and Radiosurgery Instruments - Hardware AccessoriesMDR 100.0% Class I · n=88terminalRegistered in EUDAMED under MDR with this code: 88 of 88 devices carry Class I on their registration (as of 8 Sep 2026).
- 88 Class I (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11019082Various Radiotherapy and Radiosurgery Instruments - Software AccessoriesMDR 2 classes · n=53terminalRegistered in EUDAMED under MDR with this code, the 53 devices are split across classes (as of 8 Sep 2026).
- 39 Class I (73.5%)
- 14 Class IIb (26.4%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11019085Various Radiotherapy and Radiosurgery Instruments - ConsumablesterminalZ11019092Various Radiotherapy and Radiosurgery Instruments - Medical Device SoftwareterminalRegistered in EUDAMED under MDR with this code, the 183 devices are split across classes (as of 8 Sep 2026).
- 120 Class I (65.5%)
- 57 Class IIb (31.1%)
- 6 Class IIa (3.2%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11019001Caesium Therapy EquipmentterminalZ11019002Cobalt Therapy Equipmentterminal
Z1103Diagnostic and Interventional Radiology InstrumentsZ110301Digital Angiography SystemsZ11030101Mobile Angiography Systems for Angioplasty and CatheterizationterminalZ11030102Stationary Angiography Systems for Angiographic and Cardiologic StudiesMDR 2 classes · n=99MDD 100.0% Class IIb · n=60terminalRegistered in EUDAMED under MDR with this code, the 99 devices are split across classes (as of 8 Sep 2026).
- 62 Class IIb (62.6%)
- 37 Class I (37.3%)
Registered in EUDAMED under MDD with this code: 60 of 60 devices carry Class IIb on their registration (as of 8 Sep 2026).
- 60 Class IIb (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
Z11030103Biplanar Angiography SystemsterminalZ11030180Digital Angiography Systems - Hardware AccessoriesterminalZ11030182Digital Angiography Systems - Software AccessoriesterminalZ11030185Digital Angiography Systems - ConsumablesterminalRegistered in EUDAMED under MDR with this code, the 51 devices are split across classes (as of 8 Sep 2026).
- 29 Class IIb (56.8%)
- 22 Class IIa (43.1%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z110302Mammography SystemsZ11030201Conventional Mammography SystemsterminalRegistered in EUDAMED under MDR with this code, the 37 devices are split across classes (as of 8 Sep 2026).
- 34 Class IIb (91.8%)
- 3 Class IIa (8.1%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11030280Mammography Systems - Hardware AccessoriesRegistered in EUDAMED under MDR with this code, the 24 devices are split across classes (as of 8 Sep 2026).
- 22 Class I (91.6%)
- 2 Class IIb (8.3%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Registered in EUDAMED under MDR with this code: 32 of 32 devices carry Class I on their registration (as of 8 Sep 2026).
- 32 Class I (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11030282Mammography Systems - Software AccessoriesterminalZ11030285Mammography Systems - ConsumablesterminalZ11030292Mammography Systems - Medical Device Softwareterminal
Z110303Instruments for Extraoral Dental RadiologyZ11030301Equipment for Extraoral Dental RadiologyZ1103030101Equipment for Extraoral Dental Radiology, ConventionalterminalRegistered in EUDAMED under MDR with this code: 90 of 91 devices carry Class IIb on their registration (as of 8 Sep 2026).
- 90 Class IIb (98.9%)
- 1 Class IIa (1.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11030380Instruments for Extraoral Dental Radiology - Hardware AccessoriesMDR 3 classes · n=26terminalRegistered in EUDAMED under MDR with this code, the 26 devices are split across classes (as of 8 Sep 2026).
- 16 Class IIb (61.5%)
- 8 Class IIa (30.7%)
- 2 Class I (7.6%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11030382Instruments for Extraoral Dental Radiology - Software AccessoriesterminalZ11030385Instruments for Extraoral Dental Radiology - ConsumablesterminalZ11030392Instruments for Extraoral Dental Radiology - Medical Device Softwareterminal
Z110304Instruments for Endoral RadiologyZ11030401Endoral Radiology EquipmentZ1103040101Equipment for Conventional Endoral RadiologyMDR 3 classes · n=43MDD 100.0% Class IIb · n=20terminalRegistered in EUDAMED under MDR with this code, the 43 devices are split across classes (as of 8 Sep 2026).
- 25 Class IIb (58.1%)
- 15 Class IIa (34.8%)
- 3 Class I (6.9%)
Registered in EUDAMED under MDD with this code: 20 of 20 devices carry Class IIb on their registration (as of 8 Sep 2026).
- 20 Class IIb (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
Registered in EUDAMED under MDR with this code, the 146 devices are split across classes (as of 8 Sep 2026).
- 71 Class IIa (48.6%)
- 66 Class IIb (45.2%)
- 9 Class I (6.1%)
Registered in EUDAMED under MDD with this code, the 38 devices are split across classes (as of 8 Sep 2026).
- 31 Class IIa (81.5%)
- 7 Class IIb (18.4%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
Z11030402Systems for Intraoral Digital VideoradiographyMDR 2 classes · n=125MDD 100.0% Class IIa · n=25terminalRegistered in EUDAMED under MDR with this code, the 125 devices are split across classes (as of 8 Sep 2026).
- 65 Class I (52.0%)
- 60 Class IIa (48.0%)
Registered in EUDAMED under MDD with this code: 25 of 25 devices carry Class IIa on their registration (as of 8 Sep 2026).
- 25 Class IIa (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
Registered in EUDAMED under MDR with this code: 45 of 45 devices carry Class IIa on their registration (as of 8 Sep 2026).
- 45 Class IIa (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11030482Instruments for Radiological SectionterminalRegistered in EUDAMED under MDR with this code: 33 of 33 devices carry Class I on their registration (as of 8 Sep 2026).
- 33 Class I (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11030492Instruments for Digital Endoral Radiology - Medical Device Softwareterminal
Z110305Radiology InstrumentsRegistered in EUDAMED under MDR with this code: 81 of 84 devices carry Class I on their registration (as of 8 Sep 2026).
- 81 Class I (96.4%)
- 3 Class IIb (3.5%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Registered in EUDAMED under MDR with this code: 22 of 23 devices carry Class I on their registration (as of 8 Sep 2026).
- 22 Class I (95.6%)
- 1 Class IIb (4.3%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Registered in EUDAMED under MDR with this code: 244 of 248 devices carry Class I on their registration (as of 8 Sep 2026).
- 244 Class I (98.3%)
- 4 Class IIb (1.6%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11030504Tilting Tables for Radiology EquipmentterminalZ11030505Tomography TablesterminalRegistered in EUDAMED under MDR with this code: 60 of 60 devices carry Class I on their registration (as of 8 Sep 2026).
- 60 Class I (100.0%)
Registered in EUDAMED under MDD with this code: 68 of 68 devices carry Class IIb on their registration (as of 8 Sep 2026).
- 68 Class IIb (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
Z11030507TomographsterminalRegistered in EUDAMED under MDR with this code, the 196 devices are split across classes (as of 8 Sep 2026).
- 136 Class IIb (69.3%)
- 36 Class I (18.3%)
- 24 Class IIa (12.2%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Registered in EUDAMED under MDR with this code, the 49 devices are split across classes (as of 8 Sep 2026).
- 34 Class IIa (69.3%)
- 13 Class IIb (26.5%)
- 2 Class I (4.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Registered in EUDAMED under MDR with this code: 124 of 124 devices carry Class I on their registration (as of 8 Sep 2026).
- 124 Class I (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Registered in EUDAMED under MDR with this code, the 92 devices are split across classes (as of 8 Sep 2026).
- 46 Class IIb (50.0%)
- 38 Class IIa (41.3%)
- 8 Class I (8.6%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Registered in EUDAMED under MDR with this code, the 278 devices are split across classes (as of 8 Sep 2026).
- 181 Class I (65.1%)
- 81 Class IIb (29.1%)
- 16 Class IIa (5.7%)
Registered in EUDAMED under MDD with this code: 87 of 87 devices carry Class IIb on their registration (as of 8 Sep 2026).
- 87 Class IIb (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
Z110306Computed Tomographs (Ct)Registered in EUDAMED under MDR with this code: 24 of 24 devices carry Class IIb on their registration (as of 8 Sep 2026).
- 24 Class IIb (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11030602Computed Tomographs - Exceeding 2 Layers But Less Than 16 LayersterminalZ11030603Computed Tomographs - 16 Layers or More But Less Than 64 LayersMDR 100.0% Class IIb · n=49terminalRegistered in EUDAMED under MDR with this code: 49 of 49 devices carry Class IIb on their registration (as of 8 Sep 2026).
- 49 Class IIb (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11030605Computed Tomographs - 64 Layers or More But Less Than 128 LayersMDR 100.0% Class IIb · n=33terminalRegistered in EUDAMED under MDR with this code: 33 of 33 devices carry Class IIb on their registration (as of 8 Sep 2026).
- 33 Class IIb (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11030606Computed Tomographs - 128 Layers or More But Less Than 256 LayersMDR 100.0% Class IIb · n=55terminalRegistered in EUDAMED under MDR with this code: 55 of 55 devices carry Class IIb on their registration (as of 8 Sep 2026).
- 55 Class IIb (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Registered in EUDAMED under MDR with this code: 25 of 25 devices carry Class IIb on their registration (as of 8 Sep 2026).
- 25 Class IIb (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11030680Computed Tomographs (Ct) - Hardware AccessoriesterminalRegistered in EUDAMED under MDR with this code, the 66 devices are split across classes (as of 8 Sep 2026).
- 54 Class IIa (81.8%)
- 7 Class I (10.6%)
- 5 Class IIb (7.5%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11030685Computed Tomographs (Ct) - ConsumablesterminalRegistered in EUDAMED under MDR with this code, the 131 devices are split across classes (as of 8 Sep 2026).
- 113 Class IIa (86.2%)
- 12 Class IIb (9.1%)
- 6 Class I (4.5%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Registered in EUDAMED under MDR with this code, the 39 devices are split across classes (as of 8 Sep 2026).
- 17 Class I (43.5%)
- 17 Class IIb (43.5%)
- 5 Class IIa (12.8%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z110307Remote Control TablesRegistered in EUDAMED under MDR with this code, the 28 devices are split across classes (as of 8 Sep 2026).
- 16 Class IIb (57.1%)
- 12 Class I (42.8%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Registered in EUDAMED under MDR with this code, the 38 devices are split across classes (as of 8 Sep 2026).
- 35 Class IIb (92.1%)
- 3 Class I (7.8%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11030703Remote Control Tables with Conventional Multifunctional ArchterminalZ11030704Remote Control Tables with Digital Multifunctional ArchterminalZ11030780Remote Control Tables - Hardware AccessoriesterminalZ11030782Remote Control Tables - Software AccessoriesterminalZ11030785Remote Control Tables - ConsumablesterminalZ11030792Remote Control Tables - Medical Device Softwareterminal
Registered in EUDAMED under MDR with this code: 152 of 155 devices carry Class IIb on their registration (as of 8 Sep 2026).
- 152 Class IIb (98.0%)
- 3 Class I (1.9%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z110311Direct Digital Radiology (Dr) SystemsZ11031101Multifunctional Systems for Direct Digital RadiologyMDR 3 classes · n=437MDD 2 classes · n=45terminalRegistered in EUDAMED under MDR with this code, the 437 devices are split across classes (as of 8 Sep 2026).
- 298 Class IIb (68.1%)
- 128 Class IIa (29.2%)
- 11 Class I (2.5%)
Registered in EUDAMED under MDD with this code, the 45 devices are split across classes (as of 8 Sep 2026).
- 36 Class IIb (80.0%)
- 9 Class IIa (20.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
Registered in EUDAMED under MDR with this code, the 20 devices are split across classes (as of 8 Sep 2026).
- 16 Class IIa (80.0%)
- 4 Class IIb (20.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11031180Systems for Direct Digital Radiology (Dr) - Hardware AccessoriesMDR 3 classes · n=202MDD 2 classes · n=45terminalRegistered in EUDAMED under MDR with this code, the 202 devices are split across classes (as of 8 Sep 2026).
- 101 Class IIa (50.0%)
- 100 Class I (49.5%)
- 1 Class IIb (0.4%)
Registered in EUDAMED under MDD with this code, the 45 devices are split across classes (as of 8 Sep 2026).
- 37 Class IIb (82.2%)
- 8 Class IIa (17.7%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
Z11031182Systems for Direct Digital Radiology (Dr) - Software AccessoriesMDR 2 classes · n=52terminalRegistered in EUDAMED under MDR with this code, the 52 devices are split across classes (as of 8 Sep 2026).
- 48 Class IIa (92.3%)
- 4 Class IIb (7.6%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11031192Systems for Direct Digital Radiology (Dr) - Medical Device SoftwareMDR 2 classes · n=30terminalRegistered in EUDAMED under MDR with this code, the 30 devices are split across classes (as of 8 Sep 2026).
- 26 Class IIb (86.6%)
- 4 Class IIa (13.3%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z110312Cone Beam Computed Tomographs (Cbct)terminalZ110390Various Instruments for Radiodiagnostics and Interventional ProceduresZ11039001AngiographsterminalZ11039002ArteriographsterminalZ11039003Multiformat CamerasterminalZ11039004Television SystemsterminalRegistered in EUDAMED under MDR with this code: 71 of 72 devices carry Class IIb on their registration (as of 8 Sep 2026).
- 71 Class IIb (98.6%)
- 1 Class IIa (1.3%)
Registered in EUDAMED under MDD with this code: 131 of 131 devices carry Class IIb on their registration (as of 8 Sep 2026).
- 131 Class IIb (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
Z11039006Radiology Control UnitsterminalZ11039007CraniostatsterminalZ11039008Automatic Exposure MetersterminalRegistered in EUDAMED under MDR with this code: 40 of 42 devices carry Class IIb on their registration (as of 8 Sep 2026).
- 40 Class IIb (95.2%)
- 2 Class I (4.7%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Registered in EUDAMED under MDR with this code: 80 of 80 devices carry Class I on their registration (as of 8 Sep 2026).
- 80 Class I (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11039011High Voltage X-Ray GeneratorsMDR 100.0% Class IIb · n=427MDD 95.4% Class IIb · n=22terminalRegistered in EUDAMED under MDR with this code: 427 of 427 devices carry Class IIb on their registration (as of 8 Sep 2026).
- 427 Class IIb (100.0%)
Registered in EUDAMED under MDD with this code: 21 of 22 devices carry Class IIb on their registration (as of 8 Sep 2026).
- 21 Class IIb (95.4%)
- 1 Class IIa (4.5%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
Registered in EUDAMED under MDR with this code: 286 of 290 devices carry Class IIb on their registration (as of 8 Sep 2026).
- 286 Class IIb (98.6%)
- 4 Class I (1.3%)
Registered in EUDAMED under MDD with this code: 64 of 64 devices carry Class IIb on their registration (as of 8 Sep 2026).
- 64 Class IIb (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
Registered in EUDAMED under MDR with this code, the 56 devices are split across classes (as of 8 Sep 2026).
- 50 Class IIb (89.2%)
- 6 Class IIa (10.7%)
Registered in EUDAMED under MDD with this code, the 60 devices are split across classes (as of 8 Sep 2026).
- 42 Class IIa (70.0%)
- 15 Class IIb (25.0%)
- 3 Class I (5.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
Registered in EUDAMED under MDD with this code, the 21 devices are split across classes (as of 8 Sep 2026).
- 18 Class IIb (85.7%)
- 3 Class IIa (14.2%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
Registered in EUDAMED under MDR with this code: 38 of 38 devices carry Class I on their registration (as of 8 Sep 2026).
- 38 Class I (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Registered in EUDAMED under MDR with this code: 174 of 174 devices carry Class IIb on their registration (as of 8 Sep 2026).
- 174 Class IIb (100.0%)
Registered in EUDAMED under MDD with this code: 60 of 60 devices carry Class IIb on their registration (as of 8 Sep 2026).
- 60 Class IIb (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
Registered in EUDAMED under MDR with this code: 334 of 334 devices carry Class IIb on their registration (as of 8 Sep 2026).
- 334 Class IIb (100.0%)
Registered in EUDAMED under MDD with this code: 58 of 58 devices carry Class IIb on their registration (as of 8 Sep 2026).
- 58 Class IIb (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
Z11039018SerialographsterminalZ11039019Angiography Tube SupportsterminalZ11039020Angiography TablesterminalRegistered in EUDAMED under MDR with this code, the 53 devices are split across classes (as of 8 Sep 2026).
- 30 Class IIb (56.6%)
- 23 Class IIa (43.3%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11039080Various Radiodiagnostic and Interventional Instruments - Hardware AccessoriesMDR 3 classes · n=203terminalRegistered in EUDAMED under MDR with this code, the 203 devices are split across classes (as of 8 Sep 2026).
- 111 Class I (54.6%)
- 91 Class IIb (44.8%)
- 1 Class IIa (0.4%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11039082Various Radiodiagnostic and Interventional Instruments - Software AccessoriesMDR 3 classes · n=25MDD 100.0% Class IIa · n=58terminalRegistered in EUDAMED under MDR with this code, the 25 devices are split across classes (as of 8 Sep 2026).
- 16 Class IIb (64.0%)
- 7 Class IIa (28.0%)
- 2 Class I (8.0%)
Registered in EUDAMED under MDD with this code: 58 of 58 devices carry Class IIa on their registration (as of 8 Sep 2026).
- 58 Class IIa (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
Z11039085Various Radiodiagnostic and Interventional Instruments - ConsumablesMDR 2 classes · n=44terminalRegistered in EUDAMED under MDR with this code, the 44 devices are split across classes (as of 8 Sep 2026).
- 37 Class IIa (84.0%)
- 7 Class I (15.9%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11039092Various Radiodiagnostic and Interventional Instruments - Medical Device SoftwareMDR 3 classes · n=21terminalRegistered in EUDAMED under MDR with this code, the 21 devices are split across classes (as of 8 Sep 2026).
- 8 Class I (38.0%)
- 8 Class IIb (38.0%)
- 5 Class IIa (23.8%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11039099Various Radiodiagnostic and Interventional Instruments – OtherMDR 4 classes · n=256terminalRegistered in EUDAMED under MDR with this code, the 256 devices are split across classes (as of 8 Sep 2026).
- 111 Class IIb (43.3%)
- 101 Class I (39.4%)
- 41 Class IIa (16.0%)
- 3 Class III (1.1%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z1104Echography InstrumentsZ110401Ultrasound ScannersZ11040101Internal Ultrasound ScannersMDR 99.9% Class IIa · n=1,112MDD 100.0% Class IIa · n=37terminalRegistered in EUDAMED under MDR with this code: 1,111 of 1,112 devices carry Class IIa on their registration (as of 8 Sep 2026).
- 1,111 Class IIa (99.9%)
- 1 Class IIb (<0.1%)
Registered in EUDAMED under MDD with this code: 37 of 37 devices carry Class IIa on their registration (as of 8 Sep 2026).
- 37 Class IIa (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
Registered in EUDAMED under MDR with this code: 42 of 42 devices carry Class IIa on their registration (as of 8 Sep 2026).
- 42 Class IIa (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11040103Portable Ultrasound ScannersMDR 99.4% Class IIa · n=1,148MDD 100.0% Class IIa · n=141terminalRegistered in EUDAMED under MDR with this code: 1,142 of 1,148 devices carry Class IIa on their registration (as of 8 Sep 2026).
- 1,142 Class IIa (99.4%)
- 6 Class I (0.5%)
Registered in EUDAMED under MDD with this code: 141 of 141 devices carry Class IIa on their registration (as of 8 Sep 2026).
- 141 Class IIa (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
Z11040104Multidisciplinary Ultrasound Scanners (Internal and Cardiology, Etc.)MDR 99.8% Class IIa · n=1,614MDD 3 classes · n=78terminalRegistered in EUDAMED under MDR with this code: 1,612 of 1,614 devices carry Class IIa on their registration (as of 8 Sep 2026).
- 1,612 Class IIa (99.8%)
- 2 Class IIb (0.1%)
Registered in EUDAMED under MDD with this code, the 78 devices are split across classes (as of 8 Sep 2026).
- 73 Class IIa (93.5%)
- 4 Class IIb (5.1%)
- 1 Class III (1.2%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
Registered in EUDAMED under MDR with this code: 20 of 20 devices carry Class IIa on their registration (as of 8 Sep 2026).
- 20 Class IIa (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Registered in EUDAMED under MDR with this code: 228 of 229 devices carry Class IIa on their registration (as of 8 Sep 2026).
- 228 Class IIa (99.5%)
- 1 Class I (0.4%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11040107EchophthalmographsterminalZ11040180Ultrasound Scanners - Hardware AccessoriesZ1104018099Ultrasound Scanners – Hardware Accessories – OtherMDR 2 classes · n=249MDD 95.0% Class I · n=80terminalRegistered in EUDAMED under MDR with this code, the 249 devices are split across classes (as of 8 Sep 2026).
- 230 Class I (92.3%)
- 19 Class IIa (7.6%)
Registered in EUDAMED under MDD with this code: 76 of 80 devices carry Class I on their registration (as of 8 Sep 2026).
- 76 Class I (95.0%)
- 4 Class IIa (5.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
Registered in EUDAMED under MDR with this code, the 22 devices are split across classes (as of 8 Sep 2026).
- 17 Class IIa (77.2%)
- 5 Class I (22.7%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Registered in EUDAMED under MDR with this code, the 276 devices are split across classes (as of 8 Sep 2026).
- 226 Class I (81.8%)
- 50 Class IIa (18.1%)
Registered in EUDAMED under MDD with this code, the 65 devices are split across classes (as of 8 Sep 2026).
- 60 Class IIa (92.3%)
- 4 Class I (6.1%)
- 1 Class IIb (1.5%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
Registered in EUDAMED under MDR with this code: 24 of 24 devices carry Class IIa on their registration (as of 8 Sep 2026).
- 24 Class IIa (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Registered in EUDAMED under MDR with this code: 120 of 123 devices carry Class IIa on their registration (as of 8 Sep 2026).
- 120 Class IIa (97.5%)
- 3 Class I (2.4%)
Registered in EUDAMED under MDD with this code: 53 of 53 devices carry Class IIa on their registration (as of 8 Sep 2026).
- 53 Class IIa (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
Z110402Ultrasound ProbesZ11040201Transcutaneous Ultrasound ProbesZ1104020101Linear–array Transcutaneous Ultrasound ProbesZ110402010101Two–dimensional Linear–array Transcutaneous Ultrasound ProbesMDR 99.7% Class IIa · n=360MDD 2 classes · n=161terminalRegistered in EUDAMED under MDR with this code: 359 of 360 devices carry Class IIa on their registration (as of 8 Sep 2026).
- 359 Class IIa (99.7%)
- 1 Class I (0.2%)
Registered in EUDAMED under MDD with this code, the 161 devices are split across classes (as of 8 Sep 2026).
- 149 Class IIa (92.5%)
- 12 Class I (7.4%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
Z110402010102Multidimensional Linear–array Transcutaneous Ultrasound Probesterminal
Z1104020102Curvilinear Transcutaneous Ultrasound Probes (Convex–array)Z110402010201Curvilinear Transcutaneous Two–dimensional Ultrasound Probes (Convex–array)MDR 100.0% Class IIa · n=280MDD 98.2% Class IIa · n=113terminalRegistered in EUDAMED under MDR with this code: 280 of 280 devices carry Class IIa on their registration (as of 8 Sep 2026).
- 280 Class IIa (100.0%)
Registered in EUDAMED under MDD with this code: 111 of 113 devices carry Class IIa on their registration (as of 8 Sep 2026).
- 111 Class IIa (98.2%)
- 2 Class I (1.7%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
Z110402010202Curvilinear Transcutaneous Multidimensional Ultrasound Probes (Convex–array)MDR 100.0% Class IIa · n=46terminalRegistered in EUDAMED under MDR with this code: 46 of 46 devices carry Class IIa on their registration (as of 8 Sep 2026).
- 46 Class IIa (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z1104020103Transcutaneous Ultrasound Sector Probes (Phased Array)Z110402010301Transcutaneous Ultrasound Sector Probes (Phased Array), Two–dimensionalMDR 99.3% Class IIa · n=166MDD 100.0% Class IIa · n=82terminalRegistered in EUDAMED under MDR with this code: 165 of 166 devices carry Class IIa on their registration (as of 8 Sep 2026).
- 165 Class IIa (99.3%)
- 1 Class IIb (0.6%)
Registered in EUDAMED under MDD with this code: 82 of 82 devices carry Class IIa on their registration (as of 8 Sep 2026).
- 82 Class IIa (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
Z110402010302Transcutaneous Ultrasound Sector Probes (Phased Array), Multidimensionalterminal
Z1104020104Transcutaneous Ultrasound Active Matrix ProbesZ110402010401Transcutaneous Ultrasound Active Matrix Probes, Two–dimensionalterminalZ110402010402Transcutaneous Ultrasound Active Matrix Probes, Multidimensionalterminal
Z1104020105Cmut Array Transcutaneous Ultrasound ProbesZ110402010501Cmut Array Transcutaneous Ultrasound Probes, Two–dimensionalterminalZ110402010502Cmut Array Transcutaneous Ultrasound Probes, Multidimensionalterminal
Z11040202Endocavitary Ultrasound ProbesZ1104020201Endocavitary Ultrasound Probes, Two–dimensionalMDR 100.0% Class IIa · n=152MDD 2 classes · n=52terminalRegistered in EUDAMED under MDR with this code: 152 of 152 devices carry Class IIa on their registration (as of 8 Sep 2026).
- 152 Class IIa (100.0%)
Registered in EUDAMED under MDD with this code, the 52 devices are split across classes (as of 8 Sep 2026).
- 41 Class IIa (78.8%)
- 11 Class I (21.1%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
Registered in EUDAMED under MDR with this code: 38 of 38 devices carry Class IIa on their registration (as of 8 Sep 2026).
- 38 Class IIa (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11040203Transesophageal Ultrasound ProbesRegistered in EUDAMED under MDR with this code: 34 of 34 devices carry Class IIa on their registration (as of 8 Sep 2026).
- 34 Class IIa (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z1104020302Transesophageal Ultrasound Probes, Multidimensionalterminal
Registered in EUDAMED under MDR with this code, the 176 devices are split across classes (as of 8 Sep 2026).
- 163 Class IIa (92.6%)
- 13 Class I (7.3%)
Registered in EUDAMED under MDD with this code, the 78 devices are split across classes (as of 8 Sep 2026).
- 42 Class III (53.8%)
- 36 Class IIa (46.1%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
Z110490Various Ultrasound InstrumentsRegistered in EUDAMED under MDR with this code, the 61 devices are split across classes (as of 8 Sep 2026).
- 55 Class I (90.1%)
- 6 Class IIa (9.8%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11049082Various Ultrasound Instruments - Software AccessoriesterminalRegistered in EUDAMED under MDR with this code, the 199 devices are split across classes (as of 8 Sep 2026).
- 157 Class I (78.8%)
- 42 Class IIa (21.1%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11049092Various Ultrasound Instruments - Medical Device SoftwareterminalRegistered in EUDAMED under MDR with this code, the 68 devices are split across classes (as of 8 Sep 2026).
- 48 Class IIa (70.5%)
- 20 Class I (29.4%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z1105Magnetic Resonance Imaging (MRI) InstrumentsZ110501Magnetic Resonance (Mr) SystemsZ11050101Sectoral Tomographs (for Tomographic Examinations of the Extremities)terminalZ11050102Open Magnet MRI Scanners with Magnetic Field Intensity Less Than or Equal to 0.5tterminalZ11050103Open Magnet MRI Scanners with Magnetic Field Intensity Greater Than 0.5tterminalZ11050104Closed Magnet MRI Scanners with Magnetic Field Less Than or Equal to 2tMDR 2 classes · n=121terminalRegistered in EUDAMED under MDR with this code, the 121 devices are split across classes (as of 8 Sep 2026).
- 94 Class IIa (77.6%)
- 27 Class IIb (22.3%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11050105Closed Magnet MRI Scanners with Magnetic Field Greater Than 2t and Less Than or Equal to 4tMDR 2 classes · n=59terminalRegistered in EUDAMED under MDR with this code, the 59 devices are split across classes (as of 8 Sep 2026).
- 33 Class IIb (55.9%)
- 26 Class IIa (44.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11050106Closed Magnet MRI Scanners with Magnetic Field Greater Than 4tterminalZ11050180Magnetic Resonance (Mr) Systems - Hardware AccessoriesZ1105018001Magnetic Resonance (Mr) Radiofrequency Surface CoilsMDR 3 classes · n=166MDD 97.8% Class IIa · n=46terminalRegistered in EUDAMED under MDR with this code, the 166 devices are split across classes (as of 8 Sep 2026).
- 96 Class I (57.8%)
- 57 Class IIa (34.3%)
- 13 Class IIb (7.8%)
Registered in EUDAMED under MDD with this code: 45 of 46 devices carry Class IIa on their registration (as of 8 Sep 2026).
- 45 Class IIa (97.8%)
- 1 Class III (2.1%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
Z1105018002Magnetic Resonance (Mr) Radiofrequency Volumetric CoilsterminalZ1105018099Magnetic Resonance (Mr) Systems - Hardware Accessories - OtherMDR 96.9% Class I · n=66terminalRegistered in EUDAMED under MDR with this code: 64 of 66 devices carry Class I on their registration (as of 8 Sep 2026).
- 64 Class I (96.9%)
- 2 Class IIa (3.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11050182Magnetic Resonance (Mr) Systems - Software AccessoriesterminalRegistered in EUDAMED under MDR with this code: 36 of 36 devices carry Class IIa on their registration (as of 8 Sep 2026).
- 36 Class IIa (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Registered in EUDAMED under MDR with this code, the 31 devices are split across classes (as of 8 Sep 2026).
- 28 Class IIa (90.3%)
- 3 Class IIb (9.6%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z110590Various Magnetic Resonance Imaging (MRI) InstrumentsZ11059001Magnetic Resonance InjectorsterminalZ11059080Various Magnetic Resonance Imaging Instruments - Hardware AccessoriesMDR 2 classes · n=112terminalRegistered in EUDAMED under MDR with this code, the 112 devices are split across classes (as of 8 Sep 2026).
- 79 Class IIa (70.5%)
- 33 Class I (29.4%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11059082Various Magnetic Resonance Imaging Instruments - Software AccessoriesterminalZ11059085Various Magnetic Resonance Imaging Instruments - ConsumablesterminalZ11059092Various Magnetic Resonance Imaging Instruments - Medical Device SoftwareterminalRegistered in EUDAMED under MDR with this code, the 87 devices are split across classes (as of 8 Sep 2026).
- 57 Class I (65.5%)
- 30 Class IIa (34.4%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z1106Digital Bioimaging Management InstrumentsRegistered in EUDAMED under MDR with this code, the 93 devices are split across classes (as of 8 Sep 2026).
- 73 Class I (78.4%)
- 20 Class IIa (21.5%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z110602Digital Computed Radiography (Cr) SystemsRegistered in EUDAMED under MDR with this code, the 55 devices are split across classes (as of 8 Sep 2026).
- 49 Class IIa (89.0%)
- 6 Class I (10.9%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11060202Multiple-Input Computed Radiography (Cr) SystemsterminalZ11060280Digital Computed Radiography (Cr) Systems - Hardware AccessoriesMDR 2 classes · n=64MDD 100.0% Class IIa · n=70terminalRegistered in EUDAMED under MDR with this code, the 64 devices are split across classes (as of 8 Sep 2026).
- 51 Class I (79.6%)
- 13 Class IIa (20.3%)
Registered in EUDAMED under MDD with this code: 70 of 70 devices carry Class IIa on their registration (as of 8 Sep 2026).
- 70 Class IIa (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
Z11060282Digital Computed Radiography (Cr) Systems - Software AccessoriesterminalZ11060285Digital Computed Radiography (Cr) Systems - ConsumablesterminalZ11060292Digital Computed Radiography (Cr) Systems - Medical Device Softwareterminal
Registered in EUDAMED under MDR with this code, the 227 devices are split across classes (as of 8 Sep 2026).
- 141 Class IIa (62.1%)
- 46 Class IIb (20.2%)
- 40 Class I (17.6%)
Registered in EUDAMED under MDD with this code, the 83 devices are split across classes (as of 8 Sep 2026).
- 56 Class IIa (67.4%)
- 15 Class I (18.0%)
- 12 Class IIb (14.4%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
Z110690Various Digital Bioimaging Management InstrumentsRegistered in EUDAMED under MDR with this code, the 27 devices are split across classes (as of 8 Sep 2026).
- 24 Class I (88.8%)
- 2 Class IIa (7.4%)
- 1 Class IIb (3.7%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11069002Juke Boxes for Optical DisksterminalZ11069003Bioimaging ServersterminalZ11069004Identification StationsterminalRegistered in EUDAMED under MDR with this code, the 94 devices are split across classes (as of 8 Sep 2026).
- 47 Class IIa (50.0%)
- 43 Class I (45.7%)
- 4 Class IIb (4.2%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11069080Various Digital Bioimaging Management Instruments - Hardware AccessoriesMDR 96.8% Class I · n=32terminalRegistered in EUDAMED under MDR with this code: 31 of 32 devices carry Class I on their registration (as of 8 Sep 2026).
- 31 Class I (96.8%)
- 1 Class IIa (3.1%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11069082Various Digital Bioimaging Management Instruments - Software AccessoriesMDR 3 classes · n=139terminalRegistered in EUDAMED under MDR with this code, the 139 devices are split across classes (as of 8 Sep 2026).
- 59 Class I (42.4%)
- 44 Class IIa (31.6%)
- 36 Class IIb (25.8%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11069085Various Digital Bioimaging Management Instruments - ConsumablesterminalZ11069092Various Digital Bioimaging Management Instruments - Medical Device SoftwareMDR 3 classes · n=203MDD 3 classes · n=25terminalRegistered in EUDAMED under MDR with this code, the 203 devices are split across classes (as of 8 Sep 2026).
- 88 Class IIb (43.3%)
- 84 Class IIa (41.3%)
- 31 Class I (15.2%)
Registered in EUDAMED under MDD with this code, the 25 devices are split across classes (as of 8 Sep 2026).
- 13 Class I (52.0%)
- 10 Class IIa (40.0%)
- 2 Class IIb (8.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
Registered in EUDAMED under MDR with this code: 138 of 140 devices carry Class I on their registration (as of 8 Sep 2026).
- 138 Class I (98.5%)
- 2 Class IIa (1.4%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z1107X–ray Film Imaging Support InstrumentsZ110701Automatic Film Loading SystemsterminalZ110702DiaphanoscopeterminalRegistered in EUDAMED under MDR with this code: 95 of 95 devices carry Class I on their registration (as of 8 Sep 2026).
- 95 Class I (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z110704X–ray Film PlayersterminalZ110705Laser Imagers for BioimagingterminalZ110706Video or Digital Bioimaging PlayersterminalZ110707ProcessorsRegistered in EUDAMED under MDR with this code: 22 of 22 devices carry Class I on their registration (as of 8 Sep 2026).
- 22 Class I (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11070702Day-Light ProcessorsterminalZ11070780Processors - Hardware AccessoriesterminalZ11070785Processors - Consumablesterminal
Z110790Various Supporting Instruments for X–ray Film ImagingZ11079001X–ray Film DensitometersterminalZ11079002Sensitometers and Densitometers for X–ray FilmsterminalZ11079003X–ray SensitometersterminalZ11079004Liquid Mixers for ProcessorsterminalZ11079005Printing MachinesterminalZ11079006Cassettes with Reinforcement Screen for X–ray FilmsterminalRegistered in EUDAMED under MDR with this code: 31 of 31 devices carry Class I on their registration (as of 8 Sep 2026).
- 31 Class I (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11079008Reinforcement Screens for X–ray Film CassettesterminalZ11079080Various Supporting Instruments for X-Ray Film System - Hardware AccessoriesterminalZ11079082Various X-Ray Film Imaging Support Instruments - Software AccessoriesterminalZ11079085Various X-Ray Film Imaging Support Instruments - ConsumablesMDR 100.0% Class I · n=76terminalRegistered in EUDAMED under MDR with this code: 76 of 76 devices carry Class I on their registration (as of 8 Sep 2026).
- 76 Class I (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11079092Various X-Ray Film Imaging Support Instruments - Medical Device SoftwareterminalRegistered in EUDAMED under MDR with this code, the 151 devices are split across classes (as of 8 Sep 2026).
- 140 Class I (92.7%)
- 11 Class IIa (7.2%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z1190Various Bioimaging and Radiotherapy InstrumentsZ119001Bone Densitometry SystemsZ11900101Gamma–ray Bone DensitometersterminalZ11900102Ultrasound Bone DensitometersterminalRegistered in EUDAMED under MDR with this code: 23 of 23 devices carry Class IIb on their registration (as of 8 Sep 2026).
- 23 Class IIb (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11900180Bone Densitometry Systems - Hardware AccessoriesterminalZ11900182Bone Densitometry Systems - Software AccessoriesterminalZ11900185Bone Densitometry Systems - ConsumablesterminalZ11900192Bone Densitometry Systems - Medical Device Softwareterminal
Registered in EUDAMED under MDR with this code, the 252 devices are split across classes (as of 8 Sep 2026).
- 147 Class IIb (58.3%)
- 105 Class I (41.6%)
Registered in EUDAMED under MDD with this code: 194 of 194 devices carry Class IIb on their registration (as of 8 Sep 2026).
- 194 Class IIb (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
Registered in EUDAMED under MDR with this code: 29 of 29 devices carry Class I on their registration (as of 8 Sep 2026).
- 29 Class I (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z119004Microfilm Image ReadersterminalZ119005Personal Dosimeter ReadersterminalRegistered in EUDAMED under MDR with this code, the 20 devices are split across classes (as of 8 Sep 2026).
- 10 Class I (50.0%)
- 7 Class IIb (35.0%)
- 3 Class IIa (15.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z119008Bioimaging Visualization and/or Diagnostic Report Viewing MonitorsRegistered in EUDAMED under MDR with this code, the 816 devices are split across classes (as of 8 Sep 2026).
- 532 Class I (65.1%)
- 284 Class IIa (34.8%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Registered in EUDAMED under MDR with this code: 901 of 902 devices carry Class I on their registration (as of 8 Sep 2026).
- 901 Class I (99.8%)
- 1 Class IIa (0.1%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11900880Bioimaging Visualization and/or Diagnostic Report Viewing Monitors - Hardware AccessoriesMDR 100.0% Class I · n=27terminalRegistered in EUDAMED under MDR with this code: 27 of 27 devices carry Class I on their registration (as of 8 Sep 2026).
- 27 Class I (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z11900885Bioimaging Visualization and/or Diagnostic Report Viewing Monitors- Consumables Accessoriesterminal
Registered in EUDAMED under MDR with this code, the 94 devices are split across classes (as of 8 Sep 2026).
- 88 Class I (93.6%)
- 6 Class IIb (6.3%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z119011Mammography Ecography or Radiography Stereotactic SystemsterminalZ119012Closed Circuit Television SystemsterminalZ119013ThermographsterminalRegistered in EUDAMED under MDR with this code: 55 of 56 devices carry Class I on their registration (as of 8 Sep 2026).
- 55 Class I (98.2%)
- 1 Class IIa (1.7%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z119080Various Bioimaging and Radiotherapy Instruments - Hardware AccessoriesMDR 2 classes · n=56MDD 100.0% Class I · n=100terminalRegistered in EUDAMED under MDR with this code, the 56 devices are split across classes (as of 8 Sep 2026).
- 30 Class IIa (53.5%)
- 26 Class I (46.4%)
Registered in EUDAMED under MDD with this code: 100 of 100 devices carry Class I on their registration (as of 8 Sep 2026).
- 100 Class I (100.0%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
Z119082Various Bioimaging and Radiotherapy Instruments - Software AccessoriesMDR 3 classes · n=45terminalRegistered in EUDAMED under MDR with this code, the 45 devices are split across classes (as of 8 Sep 2026).
- 18 Class I (40.0%)
- 16 Class IIa (35.5%)
- 11 Class IIb (24.4%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Z119085Various Bioimaging and Radiotherapy Instruments - ConsumablesterminalZ119092Various Bioimaging and Radiotherapy Instruments - Medical Device SoftwareMDR 96.1% Class IIa · n=157terminalRegistered in EUDAMED under MDR with this code: 151 of 157 devices carry Class IIa on their registration (as of 8 Sep 2026).
- 151 Class IIa (96.1%)
- 4 Class I (2.5%)
- 2 Class IIb (1.2%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
Registered in EUDAMED under MDR with this code: 407 of 424 devices carry Class I on their registration (as of 8 Sep 2026).
- 407 Class I (95.9%)
- 13 Class IIb (3.0%)
- 4 Class IIa (0.9%)
Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.
How Z11 is structured
The Bioimaging and Radiotherapy Instruments branch runs 5 levels deep. 57 entries below are branch headings that group other codes rather than naming a device, so a classification has to resolve all the way down to one of the 308 codes marked terminal.
16 terminal codes are “- Other” entries and 33 are “- Accessories” entries, 16% of the branch. An “- Other” code is the residual slot for devices its siblings do not name, so it is worth ruling out every specific sibling before settling on one.
The largest sub-branch is Z1103 (Diagnostic and Interventional Radiology Instruments), holding 91 of the 308 terminal codes.
Frequently asked questions
- Which Z11 codes can be used in a EUDAMED device record?
- 308 of the 365 codes listed under Z11 (Bioimaging and Radiotherapy Instruments) are terminal and can be selected. The other 57 are branch headings that cannot.
- How deep is the Z11 hierarchy?
- The Z11 branch runs 5 levels below the group code. Its largest sub-branch is Z1103 (Diagnostic and Interventional Radiology Instruments), which holds 91 of the 308 terminal codes.
- How many Z11 codes are catch-all entries?
- 16 terminal codes under Z11 are "- Other" entries and 33 are "- Accessories" entries, 16% of the branch. The remaining 259 name a specific device type.
Not sure which level to stop at, or which of two plausible codes to submit? The guide to choosing an EMDN code walks the decision level by level, with a worked example and the mistakes that get a EUDAMED registration rejected.
Classifying more than a handful of devices?
EUDAMate maps your device list against all 6,773 terminal EMDN codes with confidence-scored suggestions you review and confirm. Start with a free Readiness Check on your own data.
Run a free Readiness CheckOther groups in category Z
Source: European Commission, EMDN v2026 official release. Terminal codes are the only codes accepted in a EUDAMED device record. EMDN is a nomenclature, not a risk classification. MDR/IVDR class is determined separately.