Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9610621

FEI Number

3002806450

Entity Name

BAUER UND HASELBARTH-CHIRURG GMBH

City/State/Country

ELLERAU Schleswig-Holstein, DE

Establishment Address

SAUERBRUCHSTR. 7, ELLERAU Schleswig-Holstein D-25479, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

BAUER UND HASELBARTH- (Owner Number: 8010149)

Owner / Operator Contact Address

SAUERBRUCHSTR. 7, --, ELLERAU, DE-SH D-25479, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Retractor Spreader Khaki Roll Catheter Prostate Needle Guide Collyer Pelvimeter Stethoscope Speculum Retractor Blade Probe Dilatator Catheter Hammer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	1978-03-27
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2018-07-03
KIK	Hook, Bone	General, Plastic Surgery	Class 1	878.4800	2014-04-28
KAR	Irrigator, Sinus	Ear, Nose, Throat	Class 1	874.4420	2012-06-28
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2018-07-03
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	1978-03-20
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2016-02-11
LXK	Scrapper, Skin Specimen	General, Plastic Surgery	Class 1	878.4800	2018-07-04
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2016-10-14
FBX	Sound, Urethral, Metal Or Plastic	Gastroenterology, Urology	Class 1	876.5520	1978-03-20
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-01-25
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2019-04-30
GDR	Saw, Manual And Accessories	General, Plastic Surgery	Class 1	878.4800	2011-12-01
FER	Anoscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2017-09-08
KTZ	Caliper	Orthopedic	Class 1	888.4150	2013-01-25
EXX	Probe, Rectal, Non-Powered	Gastroenterology, Urology	Class 1	876.4730	1978-03-20
HGN	Stethoscope, Fetal	Obstetrics/Gynecology	Class 1	884.2900	2013-01-25
HHM	Sound, Uterine	Obstetrics/Gynecology	Class 1	884.4530	1978-03-20
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2010-02-13
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	1978-03-20
FGM	Probe And Director, Gastro-Urology	Gastroenterology, Urology	Class 1	876.4730	1978-03-20
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2013-01-25
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	1994-05-17
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	1978-03-20
JYK	Holder, Ear Speculum	General, Plastic Surgery	Class 1	878.1800	2019-03-12
KBL	Depressor, Metal Tongue, Surgical	Ear, Nose, Throat	Class 1	874.4420	1978-03-20
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	2025-09-04
GWZ	Percussor	Neurology	Class 1	882.1700	1978-03-20
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-01-25
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	1978-03-20

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

BAUER UND HASELBARTH-

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
K953012	Boston Surgical Products, Inc.	DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS	1995-07-12

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.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610621. Last updated year: 2026. Please use registration number 9610621 when referencing this establishment in official correspondence.