Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001778198

FEI Number

3001778198

Entity Name

GUNMED TECHNIK AG

City/State/Country

WELSCHENROHR Solothurn, CH

Establishment Address

FABRIKSTRASSE 158, WELSCHENROHR Solothurn CH-4716, CH

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Gunmed Technik AG (Owner Number: 9050706)

Owner / Operator Contact Address

Fabrikstrasse 158, Welschenrohr, CH-NOTA CH-4716, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAP Model No. 801-0000

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZB	Headgear, Extraoral, Orthodontic	Dental	Class 2	872.5500	2022-10-07
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2019-12-27

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: REGISTRAR CORP Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Gunmed Technik AG

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001778198. Last updated year: 2026. Please use registration number 3001778198 when referencing this establishment in official correspondence.