EU → US 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.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

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 in the FDA register. We do not assert that it is the same company — the two registers share no common identifier, and a name alone is not proof. This entry needs a human check.

Other manufacturers in Belgium

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