Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010569

FEI Number

5822

Entity Name

WERNER HARFMANN GMBH

City/State/Country

WURMLINGEN Baden-Wurttemberg, DE

Establishment Address

SCHWALBENWEG 3, WURMLINGEN Baden-Wurttemberg 78573, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

WERNER HARFMANN GMBH (Owner Number: 8010569)

Owner / Operator Contact Address

SCHWALBENWEG 3, --, WURMLINGEN, DE-NOTA 78573, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

INSTRUMENT, SURGICAL, NON-POWERED SCISSORS, MEDICAL, DISPOSABLE WIRE TWISTER W/GUARD TC 7 1/4 WIRE TWISTER W/GUARD TC 7 1/4" FS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-04-18
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	1981-04-20
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	1983-09-27
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1983-09-27
HXS	Twister, Wire	Orthopedic	Class 1	888.4540	2013-04-18

Official Correspondent

WERNER HARFMANN

US Agent Details

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

Related Public Records

Same Entity

WERNER HARFMANN 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
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-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

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3021574846	3D LOGICS LLC	Hillsboro, OR, US
3030089866	ORTOLOG MEDIKAL SANAYI VE TICARET A.S.	Yenimahalle Ankara, TR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010569. Last updated year: 2026. Please use registration number 8010569 when referencing this establishment in official correspondence.