Ipek/silk
by Doğsan Tibbi̇ Malzeme Sanayi̇ A.Ş. 10 variants
Ref S083Model With needle(s)
Active
CE MDR CE MDD
Valid until
26 Oct 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR 00115-B | Date12 Dec 2025 | StatusActive |
| European Union | CE/MDD | NumberB-08698147917194 08698147917194 | Date24 Aug 2024 | StatusActive |
Certificates
- MDR 00115-A Active
Quality management system EU MDR
- Certifier
- KIWA CERMET ITALIA S.P.A. 0476
- Issued
- 27 Oct 2025
- Expires
- 26 Oct 2030
- MDR 00115-B Active
Technical documentation EU MDR
- Certifier
- KIWA CERMET ITALIA S.P.A. 0476
- Issued
- 12 Dec 2025
- Expires
- 26 Oct 2030
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR, CE/MDD Active
Specification
- Trade Name
- Ipek/silkİpek
- Model / Reference
- S083, With needle(s)
- Primary DI / UDI-DI
- 08698147917194
- Basic UDI-DI
- B-08698147917194, 8698147S010S0UA
- EMDN Code
- H010202020301 Silk with needle
- Device Class
- Class IIIClass IIb
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000016026
Other devices from Doğsan Tibbi̇ Malzeme Sanayi̇ A.Ş.
Properties
Other properties (12)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Sutures: 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