İpek
by Doğsan Tibbi̇ Malzeme Sanayi̇ A.Ş. 150 variants
Ref S2882Model With needle(s)
Active
CE MDR
Valid until
26 Oct 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8698147S010S0UA 08698147917552 | Date17 Jun 2026 | 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- Withdrawn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 Active
Specification
- Model / Reference
- With needle(s), S2882
- Primary DI / UDI-DI
- 08698147917552
- Basic UDI-DI
- 8698147S010S0UA
- EMDN Code
- H010202020301 Silk with needle
- Device Class
- Class 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