EU → US Device Access

Oystershell NV

BE-MF-000011797 · Belgium · Merelbeke - Melle

Oystershell NV is registered in the European database on medical devices as a manufacturer, with 86 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa86

Most frequent device types declared: X92001483, X92001704, X92001627 + X92001667, X92001752, X92001482.

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 entryOYSTERSHELLNV (BE) · FDA 3004416964
Devices in EUDAMED86
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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