Data / Medical devices / Germany / pfm medical mepro gmbh

pfm medical mepro gmbh: FDA-registered device maker in Nonnweiler-Otzenhausen Saarland, Germany, 1 510(k) clearance and 1 PMA approval

Name: pfm medical mepro gmbh FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

pfm medical mepro gmbh is registered with the FDA (registration 3005704822) in Nonnweiler-Otzenhausen Saarland, Germany. It lists 12 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated August 16, 2013. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3005704822
Address: Am Soterberg 4, Nonnweiler-Otzenhausen Saarland, Germany, 66620
Owner or operator: PFM MEDICAL GMBH (9035772)
Roles: Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer
First device listed: December 21, 1999
Registered through: 2026
Brand names listed: CTS 500 Cassette Trimming System, MULTISNARE, Micro Introducer, Nit-Occlud, Nit-Occlud PDA, Nit-Occlud PFO, Port, TISSUE PROCESSING EQUIPMENT and more

Devices it lists

Device	Product code	Class	Role	Source
Apparatus, Melting Point, Paraffin	IDT	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Bottle, Collection, Vacuum	KDQ	2	Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Catheter Introducer Kit	OFC	2	Contract manufacturer	accessdata.fda.gov
Catheter, Embolectomy	DXE	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	LJS	2	Contract manufacturer	accessdata.fda.gov
Device, Percutaneous Retrieval	MMX	2	Manufacturer	accessdata.fda.gov
Microtome, Sliding	KFL	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Occluder, Patent Ductus, Arteriosus	MAE	3	Complaint file establishment, Manufacturer	accessdata.fda.gov
Port & Catheter, Implanted, Subcutaneous, Intravascular	LJT	2	Contract manufacturer	accessdata.fda.gov
Transcatheter Septal Occluder	MLV	3	Complaint file establishment, Manufacturer	accessdata.fda.gov
Transcatheter Septal Occluder (Atrial)	OZG	3	Manufacturer	accessdata.fda.gov
Transcatheter Septal Occluder (Ventricular)	OZH	3	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 24, 2002	K011783	MULTI-SNARE SET	DXE	Substantially Equivalent	Pfm Produkte Fur Die Medizin AG	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
August 16, 2013	P120009	NIT-OCCLUD PDA	MAE	4	October 17, 2024	accessdata.fda.gov

Compare with other makers

Updated October 17, 2024. 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.