EU → North America Device Access

Biedermann Motech GmbH & Co. KG

DE-MF-000005455 · Germany · Villingen-Schwenningen

Biedermann Motech GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 11 545 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb8 241
Class I1 206
Class IIa2 098

Most frequent device types declared: HWS Implantate, Haken, MESH/X-Cage, MOSS EOS, MOSS Family.

Among these devices, 4 296 are declared sterile, 9 447 implantable, 2 098 reusable.

Catalogue references include 100-001-4030S, 107-019-7065, 112-050-1120S, 113-093-1115, 115-110-4320, 116-55L-1700S.

European nomenclature codes declared: P09070302, P09070301, L091002, L091001, L091099, P09070304.

United States market access

FDA establishment registerRegistered with FDA
Matched entryBIEDERMANN MOTECH GMBH & Co. KG (DE) · FDA 8010944
Devices in EUDAMED11 545
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN11 545
Found in the U.S. device database1 759
Share15.2 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: United States only. Biedermann Motech GmbH & Co. KG is registered in the United States but was not found in the Canadian register.

Notified body certificates

CertificateStatusExpiry
1000319811supplemented2028-12-06
1000319809issued2031-07-06
1000274063issued2030-11-16
1000127297issued2028-12-06

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