MED-EL Elektromedizinische Geräte GmbH
Active in EUDAMEDAustriafrom SRN EUDAMED SRN AT-MF-000020243
- Devices
- 109
- Registrations
- EUDAMED
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 devicesMi2000 TICI UNICO FLEX28 SL Ref 46852
Regimes: CE MDR Registry: EUDAMEDMi2000 TICI UNICO FLEXSOFT Ref 46894
Regimes: CE MDR Registry: EUDAMED- Regimes: 510(k) Registry: 510(k)
mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis Ref K241142
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit Ref K241269
Regimes: 510(k) Registry: 510(k)Vibrant Soundbridge System Ref P990052
Regimes: PMA Registry: PMA
Showing 101-109 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