Rompharm Company SRL
RO-MF-000002517 · Romania · Otopeni
Rompharm Company SRL is registered in the European database on medical devices as a manufacturer, with 80 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class I | 80 |
|---|
Most frequent device types declared: HIACONNAG_IAR9, HIACON_IAPW, HIALUROM HONDRO, HIA_IA4V, HIA_T5P.
Among these devices, 80 are declared sterile, 79 implantable, 2 active.
Devices declared under this manufacturer
- BIOPORT CROSSLINK
- CARTInorm XL CHONDRO
- CHONDRYAL PLUS
- Carthyal chondro
- CombiMAX
- CuraJoint
- HIALUROM
- HIALUROM HONDRO
- HIALUROM Tendon
- KOMBIHYLAN
- Libertal
- Sertobec-Pro\t
Showing 12 of 80 declared devices.
Catalogue references include BIOPORT CROSSLINK, CARTInorm XL CHONDRO, CHONDRYAL PLUS, Carthyal chondro, HIALUROM, HIALUROM HONDRO.
European nomenclature codes declared: P900402.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 80 |
| 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 | 80 |
|---|---|
| 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. Rompharm Company SRL was not found in either the U.S. or the Canadian register.