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 IIa | 67 |
|---|
Most frequent device types declared: OCHELARI DE CITIT CU RAMĂ PARȚIALĂ, DIN PLASTIC, CU LENTILE DIN PLASTI, RAMĂ DE OCHELARI CU CADRU PARȚIAL, DIN METAL, RAMĂ DE OCHELARI CU CADRU PARȚIAL, DIN METAL ȘI PLASTIC, RAMĂ DE OCHELARI CU CADRU ÎNTREG, DIN ALTE MATERIALE, RAMĂ DE OCHELARI CU CADRU ÎNTREG, DIN METAL.
Devices declared under this manufacturer
- OCHELARI DE CITIT PERSPEKTIVE ARP101A +1.00
- ON BLACK
- PERSPEKTIVE
Showing 12 of 67 declared devices.
Catalogue references include ARP100B +1.50, ARP103A +1.50, ARP200D +1.50, ARP202A +1.50, BLK4920, ON BLACK BKA208-50-A04.
European nomenclature codes declared: Q02100201, Q0210030102, Q02100299, Q02100203, Q02100202.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 67 |
| Country of registration | Romania |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 67 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. AMC SRL was not found in either the U.S. or the Canadian register.