EU → North America Device Access

biocon Medizintechnik GmbH

DE-MF-000006429 · Germany · Mönchberg

biocon Medizintechnik GmbH is registered in the European database on medical devices as a manufacturer, with 31 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa31

Most frequent device types declared: Abdeckungen.

Among these devices, 28 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 31 declared devices.

Catalogue references include 91260100, 91480004/5, 92250014, 92460001, 92460002, 93422281.

European nomenclature codes declared: T020199, A030499.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED31
Country of registrationGermany

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN31
Found in the U.S. device database0
Share0.0 %

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: Neither register. biocon Medizintechnik GmbH was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
44910200206issued2031-01-25

Other manufacturers in Germany

All Germany manufacturers →