PDO'x
by Biosintex SRL Romania EUDAMED
Ref BX2031Model Polydioxanone monofilament absorbable sterile surgical suture EMDN H010101010101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-05944756559076 | Date15 Sep 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDD Expiring
EU market availability
Available in 32 countries, as listed in EUDAMED:
- Austria
- Belgium
- Bulgaria
- Croatia
- Cyprus
- Czechia
- Denmark
- Estonia
- Finland
- France
- Germany
- Greece
- Hungary
- Iceland
- Ireland
- Italy
- Latvia
- Liechtenstein
- Lithuania
- Luxembourg
- Malta
- Netherlands
- Northern Ireland
- Norway
- Poland
- Portugal
- Romania
- Slovakia
- Slovenia
- Spain
- Sweden
- Türkiye
Specification
- Model / Reference
- Polydioxanone monofilament absorbable sterile surgical suture, BX2031
- Primary DI / UDI-DI
- 05944756559076
- Basic UDI-DI
- B-05944756559076
- EMDN Code
- H010101010101 Polydioxanone monofilament with needle for open surgery
- Device Class
- Class III
- Market of Registration
- Romania
Manufacturer details
- EUDAMED SRN
- RO-MF-000001463
Other devices from Biosintex SRL
Properties & raw data
Show properties, registry sources and raw records
Other properties (9)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 1ef76d52-55bb-4253-82fd-0173f4b2ca94