Biotex
by Bi̇otex Medi̇kal Teksti̇l İthalat İhracat San. Ve Ti̇c. a.ş Türkiye EUDAMED
Ref RMD-322-1
EMDN T0202
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR 00087-A | Date7 Feb 2025 | StatusActive |
| European Union | CE/MDD | NumberB-TRMF000023145RMD32216P | Date10 Nov 2022 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR, CE/MDD 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
- I.V.F. DrapeSterile Drape
- Model / Reference
- RMD-322-1
- Primary DI / UDI-DI
- D-TRMF000023145RMD32216P, 08681812080170
- Basic UDI-DI
- B-TRMF000023145RMD32216P, 868181208GA1N8
- EMDN Code
- T0202, T020102
- 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 (2)
- EUDAMED 717387ab-bcb0-42a0-a6c0-8b560cd57d2b
- EUDAMED 08681812080170|868181208GA1N8