EU → US Device Access

AMC SRL

RO-MF-000019035 · Romania · HĂGHIG

AMC SRL is registered in the European database on medical devices as a manufacturer, with 67 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa67

Most frequent device types declared: RAMĂ DE OCHELARI CU CADRU ÎNTREG, DIN METAL, RAMĂ DE OCHELARI CU CADRU ÎNTREG, DIN ALTE MATERIALE, RAMĂ DE OCHELARI CU CADRU PARȚIAL, DIN METAL, RAMĂ DE OCHELARI FĂRĂ CADRU, DIN METAL ȘI PLASTIC, RAMĂ DE OCHELARI CU CADRU PARȚIAL, DIN METAL ȘI PLASTIC.

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 registerNot found in the FDA register
Devices in EUDAMED67
Country of registrationRomania
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Other manufacturers in Romania

All Romania manufacturers →