MED-EL Elektromedizinische Geräte GmbH
Active in EUDAMEDAustriafrom SRN EUDAMED SRN AT-MF-000020243
- Devices
- 109
- Registrations
- EUDAMED
At a glance
EU certificates
4 of 4 in force.
Market reach
- European Union
- EUDAMED actor, 4 certificates
What MED-EL Elektromedizinische Geräte GmbH makes
The company manufactures cochlear implant components, including partial and total middle ear prostheses for ossicular chain reconstruction, such as the mCLIP, mXACT, mGRIP, and mWING series. It also produces stapes prostheses like the mAXIS, mLOOP, and mZAM, as well as the VIBRANT Soundbridge System for conductive or mixed hearing loss. These devices are designed for surgical placement in the middle ear to restore hearing function.
The portfolio includes Class II and Class III devices, regulated under FDA 510(k) and PMA pathways. Products are listed in the U.S. regulatory system and are based in the United States.
Catalogue
Search and filter all 109 devicesShowing 1-50 of 109
Company details
- EUDAMED SRN
- AT-MF-000020243
- SRN (system / procedure pack)
- AT-PR-000036933
- EU VAT number
- ATU31722507
- EUDAMED status
- Active
- EUDAMED registered name
- MED-EL Elektromedizinische Geräte GmbH
- EUDAMED abbreviated name
- MED-EL
- Registered address
- 77a, Fürstenweg, 6020, Innsbruck, Austria
- [email protected]
- PRRC contact
- Laura Simonotti
EUDAMED certificates
4 certificates4 valid, 0 expiredMDR 4next expiry 19 Mar 2030
TÜV SÜD Product Service GmbH 0123 4 certificates
- G14 017853 0177 Active
Quality management system EU MDR
- Issued
- 6 Jul 2026
- Expires
- 5 Jul 2031
- G70 017853 0175 Active
Technical documentation EU MDR
- Issued
- 6 Jul 2026
- Expires
- 5 Jul 2031
- G70 017853 0176 Active
Technical documentation EU MDR
- Issued
- 6 Jul 2026
- Expires
- 5 Jul 2031
- G15 017853 0174 Active
Quality management system EU MDR
- Issued
- 22 Sep 2026
- Expires
- 19 Mar 2030
- Reason
- Add device or group
Frequently asked questions
How many devices does MED-EL Elektromedizinische Geräte GmbH have in the registry?
The registry currently lists 109 devices for MED-EL Elektromedizinische Geräte GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list MED-EL Elektromedizinische Geräte GmbH's devices?
Among its 50 most recently registered devices, MED-EL Elektromedizinische Geräte GmbH has devices listed in EUDAMED (50 devices).
What risk classes do MED-EL Elektromedizinische Geräte GmbH's devices fall under?
Among its 50 most recently registered devices, the classes recorded for MED-EL Elektromedizinische Geräte GmbH's devices are Class I, Class IIa and Class III. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for MED-EL Elektromedizinische Geräte GmbH?
EUDAMED lists 4 certificates for MED-EL Elektromedizinische Geräte GmbH (quality management system; technical documentation) under MDR. 3 are recorded with the status issued. The most recent was issued on 22 Sep 2026.
What are the newest devices from MED-EL Elektromedizinische Geräte GmbH in the registry?
The most recently registered devices listed for MED-EL Elektromedizinische Geräte GmbH include FineTuner (Ma210101), Mi2000 TICI UNICO FLEX26 SL T 5 mm Implant Kit, Mi2000 TICI UNICO FLEX24 SL T 5 mm Implant Kit and Mi2000 TICI UNICO Medium T 5 mm Implant Kit.