EU → North America Device Access

AGA Sanitätsartikel GmbH

DE-MF-000005876 · Germany · Löhne

AGA Sanitätsartikel GmbH is registered in the European database on medical devices as a manufacturer, with 388 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa388

Most frequent device types declared: AWL-1080, BOZ-1070/3N, BOZ-1070/3NS, DH-2000/LEIT, H-EKA 2080/H.

Among these devices, 1 are declared sterile, 71 active.

Devices declared under this manufacturer

Showing 12 of 388 declared devices.

Catalogue references include 20, 24, 44, 50, 67, 77.

European nomenclature codes declared: V080699, V080299, V0899, V08060199, V080602, V08020199.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED388
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 GTIN388
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. AGA Sanitätsartikel GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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