EU → North America Device Access

Bisinger Handels GmbH

DE-MF-000038556 · Germany · Rosenfeld

Bisinger Handels GmbH is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa11

Most frequent device types declared: Kid, Pumpentasche, Rucksack.

Among these devices, 7 are declared sterile.

Devices declared under this manufacturer

Catalogue references include E10076, E10104, S10003, S10004, S10005, S1000C.

European nomenclature codes declared: A03040199, Z12030385, A03010199, M0399, U040101.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED11
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 GTIN11
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. Bisinger Handels GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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