Bi̇otex
by Bi̇otex Medi̇kal Teksti̇l İthalat İhracat San. Ve Ti̇c. a.ş Türkiye EUDAMED
Ref SRCÖ-35MUMTT-125
EMDN T020499
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number868181208CS1PA | Date17 Oct 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- MDR 00087-A Issued
Quality management system EU MDR
- Notified body
- KIWA CERMET ITALIA S.P.A. 0476
- Issued
- 7 Feb 2025
- Expires
- 6 Feb 2030
Specification
- Device Name
- Sterile Ultra Reinforced Surgical Gown
- Model / Reference
- SRCÖ-35MUMTT-125
- Primary DI / UDI-DI
- 08681812080644, 08681812084635, 08681812084666, 08681812080859, 08681812084659
- Basic UDI-DI
- 868181208CS1PA
- EMDN Code
- T020499 Surgical gowns - other
- Device Class
- Class I
- Market of Registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000023145
Other devices from Bi̇otex Medi̇kal Teksti̇l İthalat İhracat San. Ve Ti̇c. a.ş
See all devices from Bi̇otex Medi̇kal Teksti̇l İthalat İhracat San. Ve Ti̇c. a.ş →
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (5)
- EUDAMED 83609e55-b2c2-49ef-9711-7d1bde009073
- EUDAMED 08681812084635|868181208CS1PA
- EUDAMED 08681812084666|868181208CS1PA
- EUDAMED 08681812080859|868181208CS1PA
- EUDAMED 08681812084659|868181208CS1PA