EU → North America Device Access

pfm medical gmbh

DE-MF-000039552 · Germany · Köln

pfm medical gmbh is registered in the European database on medical devices as a manufacturer, with 73 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Most frequent device types declared: Cooling Plate.

Devices declared under this manufacturer

Showing 12 of 73 declared devices.

Catalogue references include 010004, 010044, 0300320, 030056, 030064, 1509.

European nomenclature codes declared: W0202059080, W0202059005, W0202059017, W0202059085, W0202059012, W0202059013.

United States market access

FDA establishment registerRegistered with FDA
Matched entryPFM Medical GmbH (DE) · FDA 9617465
Devices in EUDAMED73
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN73
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryPFM MEDICAL, INC.

What it holds in Canada

Licences on record22
Currently active0
Class 2 devices10
Class 3 devices9
Class 4 devices3
First licensed2004-08-30

Licence types: Device Group Family (15), Device Family (6), Single Device (1).

Licensed under: REDON SETS, TIMESH, VASCULAR ACCESS CATHETER SYSTEM, JET PORT PLUS CATHETER SYSTEM, NIT-OCCLUD PDA, POWER INJECTABLE PORT.

North American profile: Both markets. pfm medical gmbh is registered in both the United States and Canada.

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