Identity
- Trade Name
- Daxton EUDAMEDDAXTON-K EUDAMED
- Device Name
- Daxton-K EUDAMED
- Model / Reference
- XK32502 EUDAMEDWith needle(s) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08698147930933 EUDAMED
- Basic UDI-DI
- B-08698147930933 EUDAMED8698147S000XKW6 EUDAMED
- EMDN Code
- H010201010501 POLYTETRAFLUOROETHYLENE (PTFE) MONOFILAMENT WITH NEEDLE EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Polyolefin/fluoropolymer suture, monofilament
Daxton by Doğsan Tibbi̇ Malzeme Sanayi̇ A.ş. — Class III — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Polyolefin/fluoropolymer suture, monofilament.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08698147930933 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-08698147930933 | Class III | Active |
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Manufacturer
- Manufacturer
- Doğsan Tibbi̇ Malzeme Sanayi̇ A.ş.
- EUDAMED SRN
- TR-MF-000016026
Sources (2)
- EUDAMED 976794fc-b832-406e-b16b-66396ea19cb3 61 fields · synced Oct 6, 2026
- EUDAMED c79fcb20-8fbc-431d-b041-ac7e06aee394 61 fields · synced Jun 19, 2026