EU → North America Device Access

Preventicus GmbH

DE-MF-000008931 · Germany · Jena

Preventicus GmbH is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa6

Among these devices, 6 are declared active.

Devices declared under this manufacturer

Catalogue references include COACH, CORE, HB Android, HB iOS, NIGHTWATCH Android, NIGHTWATCH iOS.

European nomenclature codes declared: C020599, Z12030292.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED6
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 GTIN6
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. Preventicus GmbH was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
44911221524issued2028-07-26

Other manufacturers in Germany

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