EU → North America Device Access

Ofa Bamberg GmbH

DE-MF-000008470 · Germany · Bamberg

Ofa Bamberg GmbH is registered in the European database on medical devices as a manufacturer, with 366 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa366

Most frequent device types declared: Flachstrick, Prophylaxe, Rundstrick.

Devices declared under this manufacturer

Showing 12 of 366 declared devices.

Catalogue references include 022322, 022545_L, 024304_L, 024394_L, 026541_L, 222318_L.

European nomenclature codes declared: M030405.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED366
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 GTIN366
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. Ofa Bamberg GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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