EMDN N01: Encephalic and Peripheral Nervous System Devices

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.

• N01Encephalic and Peripheral Nervous System Devices
  • N0101Neurophysiology Devices
    • N010101Electromyographic ElectrodesMDR 3 classes · n=636MDD 99.0% Class IIa · n=325terminal

      Registered in EUDAMED under MDR with this code, the 636 devices are split across classes (as of 8 Sep 2026).

      • 365 Class I (57.3%)
      • 269 Class IIa (42.2%)
      • 2 Class III (0.3%)

      Registered in EUDAMED under MDD with this code: 322 of 325 devices carry Class IIa on their registration (as of 8 Sep 2026).

      • 322 Class IIa (99.0%)
      • 3 Class I (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. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

    • N010102Electroencephalographic Electrodes
      • N01010201EEG Intracranic Electrodes
        • N0101020101EEG Cortical Electrodesterminal
        • N0101020102EEG Depth Electrodesterminal
        • N0101020199EEG Intracranic Electrodes - Otherterminal
      • N01010202EEG Extracranic ElectrodesMDR 99.7% Class I · n=461MDD 100.0% Class IIa · n=201terminal

        Registered in EUDAMED under MDR with this code: 460 of 461 devices carry Class I on their registration (as of 8 Sep 2026).

        • 460 Class I (99.7%)
        • 1 Class IIa (0.2%)

        Registered in EUDAMED under MDD with this code: 201 of 201 devices carry Class IIa on their registration (as of 8 Sep 2026).

        • 201 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.

      • N01010203EEG HeadsetsMDR 96.0% Class I · n=1,181terminal

        Registered in EUDAMED under MDR with this code: 1,134 of 1,181 devices carry Class I on their registration (as of 8 Sep 2026).

        • 1,134 Class I (96.0%)
        • 35 Class IIa (2.9%)
        • 12 Class IIb (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.

      • N01010299EEG Electrodes - OtherMDR 2 classes · n=861terminal

        Registered in EUDAMED under MDR with this code, the 861 devices are split across classes (as of 8 Sep 2026).

        • 636 Class I (73.8%)
        • 225 Class IIa (26.1%)

        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.

    • N010103Bipolar Nervous Electrostimulators, Battery-PoweredMDR 100.0% Class IIa · n=29terminal

      Registered in EUDAMED under MDR with this code: 29 of 29 devices carry Class IIa on their registration (as of 8 Sep 2026).

      • 29 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.

    • N010180Neurophysiology Devices - AccessoriesMDR 98.0% Class I · n=406terminal

      Registered in EUDAMED under MDR with this code: 398 of 406 devices carry Class I on their registration (as of 8 Sep 2026).

      • 398 Class I (98.0%)
      • 8 Class IIa (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.

    • N010199Neurophysiology Devices - OtherMDR 3 classes · n=462MDD 3 classes · n=46terminal

      Registered in EUDAMED under MDR with this code, the 462 devices are split across classes (as of 8 Sep 2026).

      • 231 Class IIa (50.0%)
      • 186 Class I (40.2%)
      • 45 Class IIb (9.7%)

      Registered in EUDAMED under MDD with this code, the 46 devices are split across classes (as of 8 Sep 2026).

      • 39 Class III (84.7%)
      • 6 Class IIa (13.0%)
      • 1 Class I (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.

  • N0102Neurologic Physiotheraphy Devices
    • N010201Tens System ElectrodesMDR 97.9% Class I · n=676terminal

      Registered in EUDAMED under MDR with this code: 662 of 676 devices carry Class I on their registration (as of 8 Sep 2026).

      • 662 Class I (97.9%)
      • 14 Class IIa (2.0%)

      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.

    • N010202Stimulation Point Locatorsterminal
    • N010280Neurological Physiotherapy Devices - Accessories
      • N01028001Sponges for the Application of Cutaneous Neurological Electrodesterminal
      • N01028002Neurological Physiotherapy Connectorsterminal
      • N01028003Neurological Electrodes Bandsterminal
      • N01028099Neurological Physiotherapy Devices - Accessories - OtherMDR 95.2% Class I · n=42terminal

        Registered in EUDAMED under MDR with this code: 40 of 42 devices carry Class I on their registration (as of 8 Sep 2026).

        • 40 Class I (95.2%)
        • 2 Class IIa (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.

    • N010299Neurologic Physiotheraphy Devices - OtherMDR 2 classes · n=448MDD 2 classes · n=35terminal

      Registered in EUDAMED under MDR with this code, the 448 devices are split across classes (as of 8 Sep 2026).

      • 421 Class I (93.9%)
      • 27 Class IIa (6.0%)

      Registered in EUDAMED under MDD with this code, the 35 devices are split across classes (as of 8 Sep 2026).

      • 26 Class IIa (74.2%)
      • 9 Class IIb (25.7%)

      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.

  • N0103Cranial Drainage Devices and Kits
    • N010301Ventricular-Peritoneal ShuntsMDD 100.0% Class III · n=2,554terminal

      Registered in EUDAMED under MDD with this code: 2,554 of 2,554 devices carry Class III on their registration (as of 8 Sep 2026).

      • 2,554 Class III (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.

    • N010302Ventricular-Atrial Shuntsterminal
    • N010303Cerebral Fluid External Drains and KitsMDD 95.2% Class III · n=84terminal

      Registered in EUDAMED under MDD with this code: 80 of 84 devices carry Class III on their registration (as of 8 Sep 2026).

      • 80 Class III (95.2%)
      • 3 Class IIa (3.5%)
      • 1 Class IIb (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. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

    • N010380Intracranial Drainage Devices and Kits - Accessories
      • N01038001Intracranial Drainage Devices Adapters and Connectors, Single-Useterminal
      • N01038002Intracranial Drainage Device Valvesterminal
      • N01038099Intracranial Drainage Devices and Kits - Accessories - OtherMDD 98.4% Class III · n=131terminal

        Registered in EUDAMED under MDD with this code: 129 of 131 devices carry Class III on their registration (as of 8 Sep 2026).

        • 129 Class III (98.4%)
        • 2 Class IIa (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.

    • N010399Intracranial Drainage Devices and Kits - OtherMDD 95.2% Class III · n=42terminal

      Registered in EUDAMED under MDD with this code: 40 of 42 devices carry Class III on their registration (as of 8 Sep 2026).

      • 40 Class III (95.2%)
      • 2 Class IIa (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. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

  • N0104Peripheral Nervous System Catheters
    • N010401Peripheral Nervous System Catheters and KitsMDR 2 classes · n=39MDD 100.0% Class IIa · n=33terminal

      Registered in EUDAMED under MDR with this code, the 39 devices are split across classes (as of 8 Sep 2026).

      • 33 Class IIb (84.6%)
      • 6 Class III (15.3%)

      Registered in EUDAMED under MDD with this code: 33 of 33 devices carry Class IIa on their registration (as of 8 Sep 2026).

      • 33 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.

    • N010480Peripheral Nervous System Catheters - Accessoriesterminal
    • N010499Peripheral Nervous System Catheters - OtherMDD 100.0% Class III · n=27terminal

      Registered in EUDAMED under MDD with this code: 27 of 27 devices carry Class III on their registration (as of 8 Sep 2026).

      • 27 Class III (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.

  • N0180Encephalic and Peripheral Nervous System Devices - Accessories
    • N018001Encephalic and Peripheral Nervous System Surgical Instruments, Single-Use
      • N01800101Encephalic and Peripheral Nervous System Surgical Forceps, Single-Useterminal
      • N01800102Encephalic and Peripheral Nervous System Surgical Scissors, Single-Useterminal
      • N01800103Encephalic and Peripheral Nervous System Needle Holders, Single-Useterminal
      • N01800104Encephalic and Peripheral Nervous System Spreaders and Retractors, Single-Useterminal
      • N01800105Encephalic and Peripheral Nervous System Surgical Blades, Single-Useterminal
      • N01800106Encephalic and Peripheral Nervous System Surgical Instrument Kits, Single-Useterminal
      • N01800199Encephalic and Peripheral Nervous System Surgical Instruments, Single-Use - Otherterminal
    • N018099Encephalic and Peripheral Nervous System Devices - Accessories - OtherMDR 2 classes · n=127MDD 3 classes · n=127terminal

      Registered in EUDAMED under MDR with this code, the 127 devices are split across classes (as of 8 Sep 2026).

      • 69 Class I (54.3%)
      • 58 Class IIa (45.6%)

      Registered in EUDAMED under MDD with this code, the 127 devices are split across classes (as of 8 Sep 2026).

      • 73 Class III (57.4%)
      • 53 Class IIa (41.7%)
      • 1 Class I (0.7%)

      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.

  • N0199Encephalic and Peripheral Nervous System Devices - OtherMDR 2 classes · n=41MDD 3 classes · n=66terminal

    Registered in EUDAMED under MDR with this code, the 41 devices are split across classes (as of 8 Sep 2026).

    • 23 Class I (56.0%)
    • 18 Class IIa (43.9%)

    Registered in EUDAMED under MDD with this code, the 66 devices are split across classes (as of 8 Sep 2026).

    • 51 Class III (77.2%)
    • 13 Class IIb (19.6%)
    • 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. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.