EU → North America Device Access

MedEnvision bv

BE-MF-000000329 · Belgium · Westerlo

MedEnvision bv is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa8

Among these devices, 1 are declared sterile.

Catalogue references include ME-FD1000L, ME-FD1000S, ME-FD2000L, ME-FD2000S, ME-FD3000L, ME-FD3000S.

European nomenclature codes declared: V80, P091399.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED8
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 GTIN8
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. MedEnvision bv was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
BE25/00000238supplemented2030-09-17

Other manufacturers in Belgium

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