EMDN P02: ENT Prostheses
Complete hierarchy for EMDN group P02 in category P (Implantable Prosthetic and Osteosynthesis Devices): 20 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.
P02ENT ProsthesesP0201Otologic ProsthesesP020101Middle Ear ImplantsRegistered in EUDAMED under MDD with this code: 158 of 158 devices carry Class IIb on their registration (as of 8 Sep 2026).
- 158 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 MDD with this code: 210 of 210 devices carry Class IIb on their registration (as of 8 Sep 2026).
- 210 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.
P02010103Eustachian Tube ProsthesisterminalP02010199Middle Ear Implants - Otherterminal
P020102External-Middle Ear ImplantsRegistered in EUDAMED under MDD with this code: 214 of 216 devices carry Class IIa on their registration (as of 8 Sep 2026).
- 214 Class IIa (99.0%)
- 2 Class IIb (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.
P02010202Tympanic ProsthesesterminalP02010299External-Middle Ear Implants- Otherterminal
P020103External Ear ProsthesesterminalRegistered in EUDAMED under MDD 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. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.
P020199Otologic Prostheses - Otherterminal
P0202Rhinology ProsthesesP020201Nasal Septal PluggersterminalP020202Nasal Sinus StentsterminalRegistered in EUDAMED under MDR with this code, the 177 devices are split across classes (as of 8 Sep 2026).
- 164 Class I (92.6%)
- 13 Class IIa (7.3%)
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.
P020299Rhinology Prostheses - Otherterminal
P0203Pharyngo-Oesophageal ProsthesesP020301Pharynx ProsthesesterminalP020399Pharyngo-Oesophageal Prostheses - Otherterminal
P0204Larynx ProsthesesterminalP0205Phonation ProsthesesterminalP0280ENT Prostheses- AccessoriesterminalP0299ENT Prostheses - Otherterminal
How P02 is structured
The ENT Prostheses branch runs 3 levels deep. 5 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 20 codes marked terminal.
6 terminal codes are “- Other” entries and 2 are “- Accessories” entries, 40% 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 P0201 (Otologic Prostheses), holding 10 of the 20 terminal codes.
Frequently asked questions
- Which P02 codes can be used in a EUDAMED device record?
- 20 of the 25 codes listed under P02 (ENT Prostheses) are terminal and can be selected. The other 5 are branch headings that cannot.
- How deep is the P02 hierarchy?
- The P02 branch runs 3 levels below the group code. Its largest sub-branch is P0201 (Otologic Prostheses), which holds 10 of the 20 terminal codes.
- How many P02 codes are catch-all entries?
- 6 terminal codes under P02 are "- Other" entries and 2 are "- Accessories" entries, 40% of the branch. The remaining 12 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 P
P01Prostheses, Facial, Odontological, and CranialP03Ocular ProsthesesP04Respiratory ProsthesesP05Oesophageal and Gastrointestinal ProsthesesP06Breast ImplantsP07Vascular and Cardiac ProsthesesP08Urogenital ProsthesesP09Orthopaedic Prostheses, Osteosynthesis Devices, Devices for Tendon and Ligament SynthesisP10Extra-Vascular Support ProsthesesP90Implantable Prosthetic and Osteosynthesis Devices - VariousSource: 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.