BIOSINTEX SRL
RO-MF-000001463 · Romania · Bucuresti
BIOSINTEX SRL is registered in the European database on medical devices as a manufacturer, with 1 628 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class I | 1 370 |
|---|---|
| Class IIb | 258 |
Most frequent device types declared: Polypropylene monofilament non-absorbable sterile surgical suture.
Among these devices, 1 618 are declared sterile, 1 628 implantable, 3 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 | 1 628 |
| 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.