Data / Medical devices / Germany / RAUMEDIC - Muenchberg

RAUMEDIC - Muenchberg: FDA-registered device maker in Helmbrechts Bavaria, Germany, 6 510(k) clearances

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

RAUMEDIC - Muenchberg is registered with the FDA (registration 3006946348) in Helmbrechts Bavaria, Germany. It lists 8 device types. The FDA files 6 510(k) clearances under its listings, the newest dated August 29, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006946348
Address: Hermann-Staudinger Strasse 2, Helmbrechts Bavaria, Germany, 95233
Owner or operator: RAUMEDIC (10024509)
Roles: Contract manufacturer, Manufacturer, Specification developer
First device listed: April 6, 2011
Registered through: 2026
Brand names listed: BOLT KIT CH9, DRILL KIT CH9, KIRO Set, MAJ-1607/1608, MPR2 logO DATALOGGER, OrganOx Metra System, RAUMEDIC-ICP-Monitoring-System, RAUMEDIC-PTO-Monitoring-System and more

Devices it lists

Device	Product code	Class	Role	Source
Anesthesia Conduction Kit	CAZ	2	Contract manufacturer	accessdata.fda.gov
Arthroscope	HRX	2	Contract manufacturer	accessdata.fda.gov
Catheter, Conduction, Anesthetic	BSO	2	Contract manufacturer	accessdata.fda.gov
Device, Monitoring, Intracranial Pressure	GWM	2	Manufacturer, Specification developer	accessdata.fda.gov
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation	QQK	3	Contract manufacturer	accessdata.fda.gov
Pump, Air, Non-Manual, For Endoscope	FEQ	2	Contract manufacturer	accessdata.fda.gov
Set, I.V. Fluid Transfer	LHI	2	Contract manufacturer	accessdata.fda.gov
Unit, Operative Dental	EIA	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
August 29, 2025	K250285	NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOL	GWM	Substantially Equivalent	Raumedic AG	accessdata.fda.gov
July 6, 2017	K171666	MPR2 logO DATALOGGER	GWM	Substantially Equivalent	Raumedic AG	accessdata.fda.gov
October 25, 2013	K130529	RAUMEDIC-PTO-MONITORING-SYSTEM	GWM	Substantially Equivalent	Raumedic AG	accessdata.fda.gov
April 11, 2012	K120252	RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM	GWM	Substantially Equivalent	Raumedic AG	accessdata.fda.gov
October 11, 2011	K112017	RAUMEDIC ICP MONITORING SYSTEM	GWM	Substantially Equivalent	Raumedic AG	accessdata.fda.gov
March 4, 2011	K103206	RAUMEDIC- ICP-MONITORING SYSTEM	GWM	Substantially Equivalent	Raumedic AG	accessdata.fda.gov

Compare with other makers

Updated August 29, 2025. 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.