FDA Registration
Active
🇦🇹 Austria
MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
Reg #: 9710014
·
FEI: 3000249315
·
Expires 2026
Products
12
Proprietary Names
33
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
- Registration Number
- 9710014
- FEI Number
- 3000249315
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- FUERSTENWEG 77A
- City
- INNSBRUCK Tirol
- Country
- AT
Regulatory Submissions
- 510(k) Number
- K260719
- PMA Number
- P990052
Owner / Operator
- Firm Name
- MED-EL ELEKTROMEDIZINISCHE GERAETE GmbH
- Operator Number
- 9042031
- Address
- Fuerstenweg 77a
- City
- Innsbruck
- State
- Tirol
- Postal Code
- 6020
- Country
- AT
US Agent
- Business Name
- MED-EL CORPORATION
- Contact Name
- Valerie Eastwood
- Address
- 2645 Meridian Pkwy Ste 100
- City
- Durham
- State
- NC
- ZIP
- 27713
- Country
- US
- [email protected]
- Phone
- 919 3547514
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2021-04-06 |
| Replacement, Ossicular Prosthesis, Total | ETA | Class 2 | Ear, Nose, Throat | No | 2026-04-14 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2018-07-27 |
| Prosthesis, Partial Ossicular Replacement | ETB | Class 2 | Ear, Nose, Throat | No | 2026-04-14 |
| Implant, Hearing, Active, Middle Ear, Partially Implanted | MPV | Class 3 | Unknown | No | 2007-11-13 |
| Tray, Surgical, Ent | MMO | Class 1 | Ear, Nose, Throat | No | 2011-04-26 |
| Implant, Cochlear | MCM | Class 3 | Unknown | No | 2007-11-13 |
| Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification | PGQ | Class 3 | Unknown | No | 2007-11-13 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2021-01-26 |
| Active Implantable Bone Conduction Hearing System | PFO | Class 2 | Ear, Nose, Throat | No | 2018-07-27 |
| Hearing Aid, Bone Conduction | LXB | Class 2 | Ear, Nose, Throat | No | 2018-05-07 |
| Gauge, Measuring | JYJ | Class 1 | Ear, Nose, Throat | No | 2026-04-14 |
Proprietary Names
SoftGrip Forceps (Ms050207)
SoftGrip Forceps SR (Ms050208)
SoftGrip Forceps 2
SoftGrip Forceps SR2
mARC Total Prosthesis
mGRIP Total Prosthesis
Torque Wrench Kit
mZAM Stapes Prosthesis
mLOOP Stapes Prosthesis
mFIX Stapes Prosthesis
mAXIS Stapes Prosthesis
Vibrant Soundbridge
mWING Stapes Prosthesis
mXACT PRO Total Prosthesis Kit
mXACT Total Prosthesis Offcenter
mXACT Total Prosthesis Center
mDISC Partial Prosthesis
mGRIP Partial Prosthesis
Surgical Instrument Tray (33509)
Sterilisation Tray
Surgical Instrument Tray (41452)
COMBI 40+ Cochlear Implant System
Maestro Cochlear Implant System
Surgical Claw 2
Medical Screwdriver (SD 2)
BONEBRIDGE
ADHEAR System
Total Prosthesis Sizer Kit
Partial Prosthesis Sizer Kit
mXACT PRO Partial Prosthesis Kit
mXACT Partial Prosthesis
mCLIP ARC Partial Prosthesis
mCLIP Partial Prosthesis
Establishment Types
Manufacture Medical Device