EU → North America Device Access

Morpheus AG

DE-MF-000012037 · Germany · Spaichingen

Morpheus AG is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa7

Most frequent device types declared: BC-16, REB-02-200, REB-02-250, REB-03-200, REB-03-250.

Among these devices, 7 are declared sterile.

Devices declared under this manufacturer

Catalogue references include BC-16, REB-02-200, REB-02-250, REB-03-200, REB-03-250, REB-04-200.

European nomenclature codes declared: V0199, A99.

United States market access

FDA establishment registerRegistered with FDA
Matched entryMORPHEUS AG (DE) · FDA 3016450051
Devices in EUDAMED7
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN7
Found in the U.S. device database7
Share100.0 %

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: United States only. Morpheus AG is registered in the United States but was not found in the Canadian register.

Other manufacturers in Germany

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