Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9710014

FEI Number

3000249315

Entity Name

MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

City/State/Country

INNSBRUCK Tirol, AT

Establishment Address

FUERSTENWEG 77A, INNSBRUCK Tirol 6020, AT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MED-EL ELEKTROMEDIZINISCHE GERAETE GmbH (Owner Number: 9042031)

Owner / Operator Contact Address

Fuerstenweg 77a, Innsbruck, AT-7 6020, AT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN170009

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2021-04-06
ETA	Replacement, Ossicular Prosthesis, Total	Ear, Nose, Throat	Class 2	874.3495	2026-04-14
HXC	Wrench	Orthopedic	Class 1	888.4540	2018-07-27
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2026-04-14
MPV	Implant, Hearing, Active, Middle Ear, Partially Implanted	Unknown	Class 3	N/A	2007-11-13
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2026-04-14
ETA	Replacement, Ossicular Prosthesis, Total	Ear, Nose, Throat	Class 2	874.3495	2026-04-14
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2026-04-14
MMO	Tray, Surgical, Ent	Ear, Nose, Throat	Class 1	874.4420	2011-04-26
MCM	Implant, Cochlear	Unknown	Class 3	N/A	2007-11-13
PGQ	Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification	Unknown	Class 3	N/A	2007-11-13
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2021-01-26
PFO	Active Implantable Bone Conduction Hearing System	Ear, Nose, Throat	Class 2	874.3340	2018-07-27

Official Correspondent

No official correspondent registered.

US Agent Details

Valerie Eastwood Business: MED-EL CORPORATION Email: Valerie.Eastwood@medel.com Phone: (919) 3547514

Related Public Records

Same Entity

MED-EL ELEKTROMEDIZINISCHE GERAETE GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K143738	Intuit Medical Products, LLC	DSS Sinusplasty Balloon Catheter	2015-08-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2012	Cochlear Americas Inc.	3	Cochlear Nucleus CI512 Cochlear Implant, REF Z209051, New with Nucleus 5, Sterile EO, Made in Australia, Cochlear Ltd 14 Mars Road, Lane Cove 2066, Australia. The cochlear implant is intended to restore a level of auditory sensation via the electrical stimulation of the auditory nerve.
Z-0044-05	Advanced Bionics	3	Advanced Bionics implantable cochlear stimulator CLARION 1.2 Models AB-5100L AB-5100R AB-5100ML/R (For Export Only) AB-5100H AB-5100H-01A

Similar Registrations

Registration Number	Establishment Name	Location
9680424	BAERAMED INSTRUMENTE GMBH	SCHWENNINGEN Baden-Wurttemberg, DE
9617426	PFAU MEDIZINISCHE INSTRUMENTE GMBH	WANFRIED Hesse, DE
3004530184	ANDERSEN CALEDONIA LTD	Bellshill Scotland, GB
3013358456	EMPIRE SURGICAL INSTRUMENTS COMPANY	Sialkot Punjab, PK
8043507	EISENHUT INSTRUMENTE GMBH	FRITTLINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710014. Last updated year: 2026. Please use registration number 9710014 when referencing this establishment in official correspondence.