EU → North America Device Access

Moovartes BV

BE-MF-000004088 · Belgium · Genk

Moovartes BV is registered in the European database on medical devices as a manufacturer, with 130 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa130

Catalogue references include S-FIT-50-001-R4, S-FIT-70-003-R2, S-FIT-80-006-U5, S-FIT-80-010-R5, S-FIT-80-032-L1, S-FIT-80-032-R2.

European nomenclature codes declared: Y061209, Y060621, Y061215, Y06120601, Y060615, Y060612.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED130
Country of registrationBelgium

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN130
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. Moovartes BV was not found in either the U.S. or the Canadian register.

Other manufacturers in Belgium

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