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: Poly(glycolide-co-Lactide) (90/10) multifilament coated absorbable s, Poly(glycolide-co-Lactide) (90/10) multifilament coated absorbable st, Polyamide (tip 6.6) suture monofilament synthetic non-absorbable ster, Polyamide (tip 6.6) suture multifilament synthetic coated non-absorbab, Polyglycolic acid multifilament coated absorbable sterile surgical sut.
Among these devices, 1 618 are declared sterile, 1 628 implantable, 3 active.
Devices declared under this manufacturer
- BIONIL MONOx
- BIONIL MULTIx
- BIOPRO
- DACRIL
- DACRIL 910
- H010101020101
Showing 12 of 1 628 declared devices.
Catalogue references include BX-PG 1270, BX-PG 1618, BX1079, BX1085, BX1094, BX1464.
European nomenclature codes declared: H010101020101, H010101020201, H010101020103, H010101020203, H010201010101, H010201020101.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 1 628 |
| 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 | 1 628 |
|---|---|
| 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. BIOSINTEX SRL was not found in either the U.S. or the Canadian register.