EU → North America Device Access

Bisanz medizinische Polster GmbH

DE-MF-000006356 · Germany · Gau-Algesheim

Bisanz medizinische Polster GmbH is registered in the European database on medical devices as a manufacturer, with 1 547 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa1 547

Most frequent device types declared: Arm-Lagerungshilfen Spezialanfertigung, Behandlungslagerungshilfen zur Positionierung, Behandlungslagerungshilfen zur Positionierung Spezialanfertigung, Fixierungen und Gurte, Lagerungskissen mit loser Füllung.

Devices declared under this manufacturer

Showing 12 of 1 547 declared devices.

Catalogue references include 1100004, 1340724PU, 13410/…folgende Bezeichnung, 1343200KL, 460023, 680004KLantist..

European nomenclature codes declared: V080302, V08068099, V0880, Y0599, V0810, V08030102.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED1 547
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 GTIN1 547
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. Bisanz medizinische Polster GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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