EU → North America Device Access

Funke Medical GmbH

DE-MF-000007784 · Germany · Raesfeld

Funke Medical GmbH is registered in the European database on medical devices as a manufacturer, with 56 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa56

Most frequent device types declared: ARTHROSEAT, Decubitus Therapy Cushion, Decubitus Therapy Matress, Decubitus Therapy Mattress, Patient Positioning Medical Cushion.

Among these devices, 2 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 56 declared devices.

Catalogue references include DO090, DO095EX, DO19, GRHF2CL, GRHF2HC, HFCC.

European nomenclature codes declared: V080702, V08030102, V080302, Q010507, Y180999, Q010506.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED56
Country of registrationGermany

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

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. Funke Medical GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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