Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611814

FEI Number

3002807010

Entity Name

FRITZ HUBER GmbH & Co. KG

City/State/Country

TUTTLINGEN Baden-Wurttemberg, DE

Establishment Address

QUERSTR. 1, TUTTLINGEN Baden-Wurttemberg D-78532, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

evonos GmbH & Co. KG (Owner Number: 8010248)

Owner / Operator Contact Address

Stockacher Str. 134, --, TUTTLINGEN, DE-BW D-78532, 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
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2013-01-14
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2013-01-14
HAE	Rongeur, Manual	Neurology	Class 2	882.4840	2010-03-22

Official Correspondent

Joerg Mans

US Agent Details

Holger Bumueller Business: Holger Bumueller Email: mail@usagent.net Phone: (828) 3958127

Related Public Records

Same Entity

evonos GmbH & Co. KG

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010726901	EVONOS GMBH & CO. KG	Tuttlingen Baden-Wurttemberg, DE

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.

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 9611814. Last updated year: 2026. Please use registration number 9611814 when referencing this establishment in official correspondence.