Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010591625

FEI Number

3010591625

Entity Name

GOMINA AG

City/State/Country

Niederwald Valais, CH

Establishment Address

Raiftstrasse 4, Niederwald Valais 3989, CH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

GOMINA AG (Owner Number: 10054790)

Owner / Operator Contact Address

Raiftstrasse 4, Niederwald, CH-VS 3989, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

blade

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2017-04-27
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2024-02-08

Official Correspondent

Bruno Erzinger

US Agent Details

Korina Akhondzadeh Business: KARA & Associates Email: korina@kara2a.com Phone: (858) 3448168

Related Public Records

Same Entity

GOMINA AG

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
K953012	Boston Surgical Products, Inc.	DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS	1995-07-12

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8043971	T.A.G. MEDICAL PRODUCTS CORPORATION LTD	GAATON Northern, IL
3027344440	TRITEX MEDICAL MANUFACTURING LLC	Mount Morris, MI, US
3011300255	W&H DENTALWERK BUERMOOS GMBH - SITE 2	BUERMOOS Salzburg, AT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010591625. Last updated year: 2026. Please use registration number 3010591625 when referencing this establishment in official correspondence.