Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006076696

FEI Number

3006076696

Entity Name

AUDIFON - GMBH & CO.KG

City/State/Country

KOLLEDA Thuringia, DE

Establishment Address

WERNER-VON-SIEMENS-STRABE 2, KOLLEDA Thuringia 99625, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AUDIFON - GmbH & Co. KG (Owner Number: 9078047)

Owner / Operator Contact Address

WERNER-VON-SIEMENS-STRASSE 2, --, KOELLEDA, DE-TH 99625, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

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Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	2005-09-28
OSM	Hearing Aid, Air-Conduction With Wireless Technology, Prescription	Ear, Nose, Throat	Class 2	874.3305	2016-11-09

Official Correspondent

Joerg Hensel

US Agent Details

Dale Thorstad Business: AudNet Hearing Group, Inc Email: dale@audnethg.com Phone: (888) 9627266

Related Public Records

Same Entity

AUDIFON - GmbH & Co. KG

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
K892457	Telstar Electronics, Inc.	TELSTAR MODEL 1/3 ITE HEARING AID	1989-06-06
K760996	Unitron Industries, Inc.	HEARING AID (MODEL 695D, 905 & 960P)	1976-11-16
K840825	Maico Hearing Instruments, Inc.	SERIES MR IN-THE-EAR CUSTOM HEARING AID	1984-03-30
K946253	Maico Hearing Instruments, Inc.	MAICO IN-THE-EAR MODEL RD 201	1995-01-30
K863975	Gn Danavox, Inc.	CUSTOM IN-THE-EAR	1986-11-07

Similar Registrations

Registration Number	Establishment Name	Location
3008713760	KENYON AUDIOLOGY	Bend, OR, US
3022507139	Zhongrui HearJoy Medical Equipment co., Ltd.	Shenzhen Guangdong, CN
3005785669	ALPS INTERNATIONAL	NEW DELHI, IN
2523819	MICROSONIC, INC.	AMBRIDGE, PA, US
3017618900	HUIZHOU GOLD ROSE TECHNOLOGY CO.,LTD	huizhou Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006076696. Last updated year: 2026. Please use registration number 3006076696 when referencing this establishment in official correspondence.