EU → North America Device Access

Hofer GmbH & Co KG

AT-MF-000002397 · Austria · Fürstenfeld

Hofer GmbH & Co KG is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb8

Among these devices, 4 are declared sterile, 8 implantable.

Devices declared under this manufacturer

Catalogue references include 750-100-080-007, 750-100-080-007-S, 750-100-080-011, 750-100-080-011-S, 750-100-090-005, 750-100-090-005-S.

European nomenclature codes declared: P09120599.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED8
Country of registrationAustria

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN8
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. Hofer GmbH & Co KG was not found in either the U.S. or the Canadian register.

Other manufacturers in Austria

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