Daxton-D
by Doğsan Tibbi̇ Malzeme Sanayi̇ A.Ş. 27 variants
Ref XD5509Model With needle(s)
Active
CE MDR
Valid until
7 Jul 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number2975-MED-2518901 | Date8 Jul 2025 | StatusActive |
Certificates
- 2975-MED-2518901 Active
Quality management system EU MDR
- Certifier
- SZUTEST Konformitätsbewertungsstelle GmbH 2975
- Issued
- 8 Jul 2025
- Expires
- 7 Jul 2030
- 2975-MED-2518901-D01 Active
Technical documentation EU MDR
- Certifier
- SZUTEST Konformitätsbewertungsstelle GmbH 2975
- Issued
- 8 Jul 2025
- Expires
- 7 Jul 2030
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- With needle(s), XD5509
- Primary DI / UDI-DI
- 08698147931114
- Basic UDI-DI
- 8698147S000XDVQ
- EMDN Code
- H010201010501 Polytetrafluoroethylene (ptfe) monofilament with 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