Data / Medical devices / Germany / Fentexmedical GMBH

Fentexmedical GMBH: FDA-registered device maker in NEUHAUSEN, BW Baden-Wurttemberg, Germany, 1 510(k) clearance

Name: Fentexmedical GMBH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Fentexmedical GMBH is registered with the FDA (registration 3006154292) in NEUHAUSEN, BW Baden-Wurttemberg, Germany. It lists 14 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 8, 2004. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Fentexmedical GMBH

FDA registration number: 3006154292
Address: Take-Off Gewerbepark 2, NEUHAUSEN, BW Baden-Wurttemberg, Germany, D 78579
Owner or operator: FENTEX MEDICAL GMBH (9093406)
Roles: Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
First device listed: October 10, 2006
Registered through: 2027
Brand names listed: ENT PROBES, LIGATURE PASSING AN, MANUAL SURGICAL INSTRUMENT, MANUAL SURGICAL INSTRUMENTS, MICROSURGICAL EAR PICKS, TUNING FORK

Devices it lists

Device	Product code	Class	Role	Source
Camera, Surgical And Accessories	KQM	1	Exporter to the US	accessdata.fda.gov
Fork, Tuning	GWX	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Instrument, Ent Manual Surgical	LRC	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Instrument, Ligature Passing And Knot Tying	HCF	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Laryngoscope, Rigid	CCW	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Nasopharyngoscope (Flexible Or Rigid)	EOB	2	Repackager or relabeler	accessdata.fda.gov
Operating Room Accessories Table Tray	FWZ	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Pick, Microsurgical Ear	JYT	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Probe, Ent	KAK	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Retractor, Ent	KAL	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Source, Carrier, Fiberoptic Light	EQH	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Speculum, Ent	EPY	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Tray, Surgical, Ent	MMO	1	Contract manufacturer, 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
January 8, 2004	K032822	ASAP SINUSCOPE 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-0	EOB	Substantially Equivalent	Asap Endoscopic Products GmbH	accessdata.fda.gov

Compare with other makers

Updated January 8, 2004. 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.