Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611616

FEI Number

3002807982

Entity Name

RAIMUND WENZLER GMBH, INSTRUMENTEN-MANUFAKTUR

City/State/Country

BALGHEIM Baden-Wurttemberg, DE

Establishment Address

STEIGACKER 22, BALGHEIM Baden-Wurttemberg 78582, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

RAIMUND WENZLER GMBH, INSTRUMENTEN-MANUFAKTUR (Owner Number: 8010361)

Owner / Operator Contact Address

STEIGACKER 22, --, BALGHEIM, DE-BW 78582, 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
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-03-19
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2000-12-07
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2019-12-18
HAE	Rongeur, Manual	Neurology	Class 2	882.4840	2006-07-12
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2008-06-22
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2000-12-07
GZX	Instrument, Microsurgical	Neurology	Class 1	882.4525	2010-04-01
HTX	Rongeur	Orthopedic	Class 1	888.4540	2000-12-07
KBS	Punch, Adenoid	Ear, Nose, Throat	Class 1	874.4420	2013-03-19
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2016-03-14
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2017-01-24
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2000-12-07
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	1986-05-05
KBD	Scissors, Nasal	Ear, Nose, Throat	Class 1	874.4420	2000-12-07

Official Correspondent

MARTIN WENZLER

US Agent Details

Angelika Scherp Business: Business Support International Email: info@bsi-fda.com Phone: (212) 3318358

Related Public Records

Same Entity

RAIMUND WENZLER GMBH, INSTRUMENTEN-MANUFAKTUR

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
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.

Similar Registrations

Registration Number	Establishment Name	Location
1055236	DEROYAL INDUSTRIES, INC.	NEW TAZEWELL, TN, US
3016825318	MECMED MEDICAL	Sialkot Punjab, PK
3000270450	Synthes GMBH	Selzach Solothurn, CH
3014967969	PACKAGING COMPLIANCE MEDICAL, LLC	Kentwood, MI, US
3014262693	Arthrex (Shanghai) Co., Ltd.	Shanghai, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611616. Last updated year: 2026. Please use registration number 9611616 when referencing this establishment in official correspondence.