EU → US Device Access

Alphadent NV

BE-MF-000000923 · Belgium · Waregem

Alphadent NV is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa12

Most frequent device types declared: H 14, 2002G, 2004G, H 2, 2001.

Among these devices, 4 are declared reusable.

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 entryALPHA DENT IMPLANTS GMBH (DE) · FDA 3015383403
Devices in EUDAMED12
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

All Belgium manufacturers →