Data / Medical devices / Germany / Bema-Gmbh & Co. KG

Bema-Gmbh & Co. KG: FDA-registered device maker in EMMINGEN Baden-Wurttemberg, Germany, 1 510(k) clearance

Name: Bema-Gmbh & Co. KG FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Bema-Gmbh & Co. KG is registered with the FDA (registration 9681129) in EMMINGEN Baden-Wurttemberg, Germany. It lists 20 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 20, 2011. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9681129
FEI number: 3007573441
Address: Rudolf Diesel-Strasse 12, EMMINGEN Baden-Wurttemberg, Germany, 78576
Owner or operator: BEMA GMBH & CO. KG (9019626)
Roles: Contract manufacturer, Manufacturer
First device listed: July 19, 2002
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Catheter	KGZ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Forceps, Ent	KAE	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Forceps, General & Plastic Surgery	GEN	1	Contract manufacturer	accessdata.fda.gov
Forceps, Wire Closure, Ent, Non-Sterile	NNQ	1	Contract manufacturer	accessdata.fda.gov
Holder, Needle, Gastroenterologic	FHQ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Hook, Surgical, General & Plastic Surgery	GDG	1	Contract manufacturer	accessdata.fda.gov
Instrument, Microsurgical	GZX	1	Contract manufacturer	accessdata.fda.gov
Instrument, Surgical, Non-Powered	HAO	1	Contract manufacturer	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Contract manufacturer	accessdata.fda.gov
Laparoscopic Accessories, Gynecologic	NWV	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Nipper, Malleus	JYR	1	Contract manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Contract manufacturer	accessdata.fda.gov
Punch, Ent	KTF	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Retractor	GAD	1	Contract manufacturer	accessdata.fda.gov
Retractor, Self-Retaining	FFO	1	Contract manufacturer	accessdata.fda.gov
Scissors, Ear	JZB	1	Contract manufacturer	accessdata.fda.gov
Scissors, General, Surgical	LRW	1	Contract manufacturer	accessdata.fda.gov
Scissors, Nasal	KBD	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Surgical Instruments, G-U, Manual (And Accessories)	KOA	1	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 20, 2011	K102921	ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIES	GEI	Substantially Equivalent	Bema-GmbH & Co. KG	accessdata.fda.gov

Compare with other makers

Updated December 20, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.