EU → US Device Access

Sanatmetal Ortopédiai és Traumatológiai Eszközöket Gyártó Kft.

HU-MF-000006772 · Hungary · Eger

Sanatmetal Ortopédiai és Traumatológiai Eszközöket Gyártó Kft. is registered in the European database on medical devices as a manufacturer, with 891 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa888
Class IIb3

Among these devices, 1 are declared sterile, 3 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 entrySANATMETAL Ltd. (HU) · FDA 3002962587
Devices in EUDAMED891
Country of registrationHungary
⚠️ 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 Hungary

All Hungary manufacturers →