PEGELAK rapid
by Doğsan Tibbi̇ Malzeme Sanayi̇ A.Ş. Türkiye EUDAMED
Ref Q4300Model With or without needle(s)
EMDN H010101020201,H010101020202
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8698147S110Q0UF | Date5 May 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- MDR 00115-A Issued
Quality management system EU MDR
- Notified body
- KIWA CERMET ITALIA S.P.A. 0476
- Issued
- 27 Oct 2025
- Expires
- 26 Oct 2030
- MDR 00115-B Issued
Technical documentation EU MDR
- Notified body
- KIWA CERMET ITALIA S.P.A. 0476
- Issued
- 12 Dec 2025
- Expires
- 26 Oct 2030
Specification
- Model / Reference
- With or without needle(s), Q4300
- Primary DI / UDI-DI
- 08698147923478
- Basic UDI-DI
- 8698147S110Q0UF
- EMDN Code
- H010101020201,H010101020202
- Device Class
- Class III
- Market of Registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000016026
Other devices from Doğsan Tibbi̇ Malzeme Sanayi̇ A.Ş.
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 08698147923478|8698147S110Q0UF