Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681129

FEI Number

3007573441

Entity Name

BEMA-GMBH & CO. KG

City/State/Country

EMMINGEN Baden-Wurttemberg, DE

Establishment Address

RUDOLF DIESEL-STRASSE 12, EMMINGEN Baden-Wurttemberg 78576, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

BEMA GMBH & CO. KG (Owner Number: 9019626)

Owner / Operator Contact Address

RUDOLF DIESEL-STRASSE 12, EMMINGEN, DE-BW 78576, 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
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2008-05-27
JYR	Nipper, Malleus	Ear, Nose, Throat	Class 1	874.4420	2008-06-19
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2007-11-24
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2008-06-19
KBD	Scissors, Nasal	Ear, Nose, Throat	Class 1	874.4420	2008-06-27
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2011-05-05
KOA	Surgical Instruments, G-U, Manual (And Accessories)	Gastroenterology, Urology	Class 1	876.4730	2011-03-08
JZB	Scissors, Ear	Ear, Nose, Throat	Class 1	874.4420	2008-05-27
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2011-06-07
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2011-04-29
NWV	Laparoscopic Accessories, Gynecologic	Obstetrics/Gynecology	Class 1	884.1720	2008-05-27
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-01-18
NNQ	Forceps, Wire Closure, Ent, Non-Sterile	Ear, Nose, Throat	Class 1	874.3540	2008-06-19
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2017-03-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-12-21
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2015-12-21
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2008-05-27
GZX	Instrument, Microsurgical	Neurology	Class 1	882.4525	2017-03-22

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

BEMA 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
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.
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.

Similar Registrations

Registration Number	Establishment Name	Location
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3032847175	BIOPHYX SURGICAL, INC.	Edgewater, MD, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681129. Last updated year: 2026. Please use registration number 9681129 when referencing this establishment in official correspondence.