EU → US 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 IIa2 098
Class I1 206

Most frequent device types declared: MOSS Family, HWS Implantate, Ti-Platzhalter/Cages, Surgical Instruments, MESH/X-Cage.

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

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

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

Notified body certificates

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

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