Bi̇otex
by Bi̇otex Medi̇kal Teksti̇l İthalat İhracat San. Ve Ti̇c. a.ş 530 variants
Ref BİO-BÖ100
Active
CE MDR
Valid until
6 Feb 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number868181208GA1N8 | Date17 Oct 2025 | StatusActive |
Certificates
- MDR 00087-A Active
Quality management system EU MDR
- Certifier
- KIWA CERMET ITALIA S.P.A. 0476
- Issued
- 7 Feb 2025
- Expires
- 6 Feb 2030
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Sterile DrapeBanded Drape
- Model / Reference
- BİO-BÖ100
- Primary DI / UDI-DI
- 08681812081375, D-TRMF000023145BIOBOPJ
- Basic UDI-DI
- 868181208GA1N8, B-TRMF000023145BIOBOPJ
- EMDN Code
- T020102, T0202
- Device Class
- Class I
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000023145
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Properties
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