EU → North America Device Access

GC Europe NV

BE-MF-000001608 · Belgium · Leuven

GC Europe NV is registered in the European database on medical devices as a manufacturer, with 1 026 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa1 026

Among these devices, 1 026 are declared implantable.

Devices declared under this manufacturer

Showing 12 of 1 026 declared devices.

Catalogue references include 870019, 870243, 874033, 875621, 875665, 876451.

European nomenclature codes declared: Q010699.

United States market access

FDA establishment registerSimilar name found — unverified
Matched entryGC EUROPE N.V. (BE) · FDA 3003775534
Devices in EUDAMED1 026
Country of registrationBelgium

⚠️ A similar name exists; we do not assert it is the same company — why.

Device-level evidence

Devices with a numeric GTIN1 026
Found in the U.S. device database982
Share95.7 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

Other manufacturers in Belgium

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