Osseous
by Eon Meditech Pvt. Ltd India EUDAMED
Ref E2128Model Middle Ear Implant
EMDN P02010102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-08906039310283 | Date3 Dec 2025 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/MDD Expiring (legacy directive)
Specification
- Device Name
- Fluoroplastic Stapes Piston (Shaft Dia.:0.4mm)
- Model / Reference
- Middle Ear Implant, E2128
- Primary DI / UDI-DI
- 08906039310283
- Basic UDI-DI
- B-08906039310283
- EMDN Code
- P02010102 Stapedioplastic prostheses
- Device Class
- Class IIb
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- IN-MF-000014457
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Eon Meditech Pvt. Ltd
Properties & raw data
Show properties, registry sources and raw records
Other properties (9)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 6b94375a-7873-42d4-a87d-a1cae5d1fac0