Pegelak
by Doğsan Tibbi̇ Malzeme Sanayi̇ A.Ş. 167 variants
Ref L35Model With or without 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-08698147924055 08698147924055 | Date28 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- Withdrawn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
- Model / Reference
- L35, With or without needle(s)
- Primary DI / UDI-DI
- 08698147924055
- Basic UDI-DI
- B-08698147924055, 8698147S110L0TY
- EMDN Code
- H010101020203 Polyglycolic with lactic acid multifilament without needle
- Device Class
- Class III
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000016026
Other devices from Doğsan Tibbi̇ Malzeme Sanayi̇ A.Ş.
Properties
Other properties (11)
- 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