Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013031133

FEI Number

3013031133

Entity Name

JOSEF BACHER GMBH

City/State/Country

Rietheim-Weilheim Baden-Wurttemberg, DE

Establishment Address

Eisenbahnstr. 19, Rietheim-Weilheim Baden-Wurttemberg 78604, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Josef Bacher GmbH (Owner Number: 10052056)

Owner / Operator Contact Address

Eisenbahnstr. 19, Rietheim-Weilheim, DE-BW 78604, 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
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2016-12-24
FGA	Kit, Nephroscope	Gastroenterology, Urology	Class 2	876.1500	2016-06-08
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2016-12-24
JYX	Punch, Attic	Ear, Nose, Throat	Class 1	874.4420	2016-12-24
EZO	Urethrotome	Gastroenterology, Urology	Class 2	876.4770	2016-06-08
KAY	Punch, Nasal	Ear, Nose, Throat	Class 1	874.4420	2016-12-24
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2016-12-24
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2016-12-24
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2016-12-24
HTX	Rongeur	Orthopedic	Class 1	888.4540	2016-12-24
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2016-12-24
JZA	Rongeur, Mastoid	Ear, Nose, Throat	Class 1	874.4420	2016-12-24
FJL	Resectoscope	Gastroenterology, Urology	Class 2	876.1500	2016-06-08
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2016-12-24

Official Correspondent

No official correspondent registered.

US Agent Details

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

Related Public Records

Same Entity

Josef Bacher 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
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
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-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

Similar Registrations

Registration Number	Establishment Name	Location
1058584	Sterigenics US LLC	Charlotte, NC, US
3020984207	SENSORENDO MEDICAL TECHNOLOGY (ZHUHAI) CO., LTD.	Zhuhai Guangdong, CN
2124215	Boston Scientific Corporation	Saint Paul, MN, US
3033434906	JIANGSU POWER-ENDO MEDICAL TECHNOLOGY CO., LTD.	Changzhou Jiangsu, CN
3008843439	HANGZHOU KANGJI MEDICAL INSTRUMENT CO., LTD.	HANGZHOU Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013031133. Last updated year: 2026. Please use registration number 3013031133 when referencing this establishment in official correspondence.