Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010254

FEI Number

3004579427

Entity Name

MANFRED HILZINGER GmbH & Co. KG

City/State/Country

TUTTLINGEN Baden-Wurttemberg, DE

Establishment Address

GAENSAECKER 50, TUTTLINGEN Baden-Wurttemberg 78532, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

MANFRED HILZINGER GMBH & CO. KG (Owner Number: 8010254)

Owner / Operator Contact Address

GANSAECKER 50, --, 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
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2008-06-26
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2003-08-07
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2013-01-17
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2017-09-15
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	1978-03-28
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	1994-01-05
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2001-02-08

Official Correspondent

No official correspondent registered.

US Agent Details

Angelika Scherp Business: BUSINESS SUPPORT INTERNATIONAL Email: info@bsi-fda.com Phone: (212) 3318358

Related Public Records

Same Entity

MANFRED HILZINGER 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
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28

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
2531819	LEAN & JONES, INC.	Jenkintown, PA, US
9710524	ULTIMATE MEDICAL PRODUCTS LTD.	SHARJAH Ash Shariqah, AE
3042228518	AKRITI OPHTHALMIC PRIVATE LIMITED	Hyderabad Telangana, IN
9612278	DUFNER INSTRUMENTE GMBH	TUTTLINGEN Baden-Wurttemberg, DE
3003039352	EPSILON EYE CARE PVT., LTD.	MUMBAI Maharashtra, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010254. Last updated year: 2026. Please use registration number 8010254 when referencing this establishment in official correspondence.