EU → North America Device Access

VISUS Health IT GmbH

DE-MF-000005585 · Germany · Bochum

VISUS Health IT GmbH is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa7

Among these devices, 7 are declared active, 7 with a measuring function.

Devices declared under this manufacturer

Catalogue references include JiveX, JiveX 5.3.0.40+, JiveX 5.4.0.18+, JiveX 5.7, JiveX 5.8.

European nomenclature codes declared: Z110603.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED7
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 GTIN7
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryVISUS HEALTH IT GMBH

North American profile: Canada only. VISUS Health IT GmbH holds a Canadian licence but was not found in the U.S. register.

Notified body certificates

CertificateStatusExpiry
7333GB448230913issued2028-01-20

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