EU → North America Device Access

Amoena Medizin-Orthopädie-Technik GmbH

DE-MF-000009133 · Germany · Raubling

Amoena Medizin-Orthopädie-Technik GmbH is registered in the European database on medical devices as a manufacturer, with 98 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa98

Most frequent device types declared: CuraLymph Comfort, CuraSupport Comfort, CuraSupport Compression, Lingerie.

Devices declared under this manufacturer

Showing 12 of 98 declared devices.

Catalogue references include 2128, 45141, 45142, 45143, 45145, 45146.

European nomenclature codes declared: Y063099, M030499.

United States market access

FDA establishment registerSimilar name found — unverified
Matched entryAMOENA MEDIZIN-ORTHOPADIE-TECHNIK GMBH (DE) · FDA 1000641183
Devices in EUDAMED98
Country of registrationGermany

⚠️ A similar name exists; we do not assert it is the same company — why.

Device-level evidence

Devices with a numeric GTIN98
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.

Other manufacturers in Germany

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