EU → North America Device Access

BIOEUROPE GmbH

DE-MF-000039230 · Germany · Lindau

BIOEUROPE GmbH is registered in the European database on medical devices as a manufacturer, with 18 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Most frequent device types declared: 1005-1, 1081-1, 1147-02, 1400-1, 7009.

Devices declared under this manufacturer

Showing 12 of 18 declared devices.

Catalogue references include 1005-1, 1081-1, 1147-02, 1400-1, 7009, 7011.

European nomenclature codes declared: W01020208, W0102160302, W0102060105, W0102160101, W0105090102, W0102060104.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED18
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 GTIN6
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. BIOEUROPE GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

All Germany manufacturers →