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: HIACON_IAPW, HIA_IA4V, HIACONNAG_IAR9, HIA_T5P, HIA_IA4V.
Among these devices, 80 are declared sterile, 79 implantable, 2 active.
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 register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 80 |
| Country of registration | Romania |
⚠️ 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.