Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025303963

FEI Number

3025303963

Entity Name

ZEMATEC GMBH

City/State/Country

Spaichingen Baden-Wurttemberg, DE

Establishment Address

Keplerstrasse 4, Spaichingen Baden-Wurttemberg 78549, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ZEMATEC GmbH (Owner Number: 10086660)

Owner / Operator Contact Address

Keplerstrasse 4, Spaichingen, DE-BW 78549, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HPN	Magnet, Permanent	Ophthalmic	Class 1	886.4445	2022-11-30
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2022-11-30
JZB	Scissors, Ear	Ear, Nose, Throat	Class 1	874.4420	2022-11-30

Official Correspondent

Martin Zepf

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

ZEMATEC 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
K914226	E.I. Dupont DE Nemours & Co., Inc.	ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK	1991-11-19

Similar Registrations

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1928237	MIDWEST STERILIZATION CORP.	JACKSON, MO, US
9616245	GEUDER AG	HEIDELBERG Baden-Wurttemberg, DE
1039131	BRUDER HEALTHCARE COMPANY	Fairfield, OH, US
3003244954	ZEPF MEDICAL INSTRUMENTS GMBH	SEITINGEN-OBERFLACHT Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025303963. Last updated year: 2026. Please use registration number 3025303963 when referencing this establishment in official correspondence.