EU → North America Device Access

SINOVO health solutions GmbH

DE-MF-000009832 · Germany · Bad Vilbel

SINOVO health solutions GmbH is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa14

Among these devices, 14 are declared active.

Devices declared under this manufacturer

Showing 12 of 14 declared devices.

Catalogue references include AUdiTE, SiDiary Android, SiDiary Online, SiDiary PC, Vivora PC, Wellion SiDiary Android.

European nomenclature codes declared: Z12040282, Z12040292.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED14
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 GTIN14
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. SINOVO health solutions GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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