EU → North America Device Access

MeVis Medical Solutions AG

DE-MF-000005418 · Germany · Bremen

MeVis Medical Solutions AG is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa10

Most frequent device types declared: 1.x, 2.4.x, 2.x.

Among these devices, 10 are declared active, 4 with a measuring function.

Devices declared under this manufacturer

Catalogue references include EIRA-1.1.4, EIRA-1.2., MVLS 1.3 ROW / MVLS-View 1.3-S ROW, MVLS-1.2-F / MVLS-1.2-V, MVLS-1.3, Veo-2000-CS.

European nomenclature codes declared: Z11030682, Z11030592.

United States market access

FDA establishment registerRegistered with FDA
Matched entryMEVIS MEDICAL SOLUTIONS AG (DE) · FDA 3010601176
Devices in EUDAMED10
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN10
Found in the U.S. device database6
Share60.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryMEVIS MEDICAL SOLUTIONS AG

What it holds in Canada

Licences on record3
Currently active0
Class 2 devices3
First licensed2004-10-05

Licence types: Single Device (2), Device Family (1).

Licensed under: VISIA CT LUNG SYSTEM, VEOLITY, VISIA LUNGCAD.

North American profile: Both markets. MeVis Medical Solutions AG is registered in both the United States and Canada.

Notified body certificates

CertificateStatusExpiry
6092GB448251125supplemented2026-09-29

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