EU → North America Device Access

BolusCare UG (haftungsbeschränkt)

DE-MF-000056518 · Germany · Meinerzhagen

BolusCare UG (haftungsbeschränkt) is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa9

Most frequent device types declared: 80g.

Catalogue references include BC-0030-A, BC-0030-A/B, BC-0030-B, BC-0080-A, BC-0080-B, BC-0150-A.

European nomenclature codes declared: V0804.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED9
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 GTIN9
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. BolusCare UG (haftungsbeschränkt) was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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