Tsm
by Medi̇koki̇m Tibbi̇ Ve Ki̇myevi̇ Malz.san. Ve Ti̇c.a.ş. 10 variants
Ref TSM 301
Active
CE MDR
Valid until
29 May 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number869888147TF03V024L 08698881472423 | Date8 Oct 2026 | StatusActive |
Certificates
- MDR 00068-C Active
Quality management system EU MDR
- Certifier
- KIWA CERMET ITALIA S.P.A. 0476
- Issued
- 30 May 2025
- Expires
- 29 May 2030
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Fototerapi Göz Koruma Bandı
- Model / Reference
- TSM 301
- Primary DI / UDI-DI
- 08698881472423
- Basic UDI-DI
- 869888147TF03V024L
- EMDN Code
- V0201 Phototherapy masks
- Device Class
- Class I
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000020142
Other devices from Medi̇koki̇m Tibbi̇ Ve Ki̇myevi̇ Malz.san. Ve Ti̇c.a.ş.
See all devices from Medi̇koki̇m Tibbi̇ Ve Ki̇myevi̇ Malz.san. Ve Ti̇c.a.ş. →
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