EU → North America Device Access

Schaefers Medizintechnik GmbH

DE-MF-000006991 · Germany · Velen

Schaefers Medizintechnik GmbH 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: Irrigationsschlauchbeutel, Irrimed classic, Schlauchsystem.

Among these devices, 2 are declared active.

Devices declared under this manufacturer

Catalogue references include 3000E, 3010, 3100, 3200, 4000, 5000.

European nomenclature codes declared: A0380, A100399, A03010299, A100302.

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. Schaefers Medizintechnik GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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