Identity
- Trade Name
- DAXTON-K EUDAMED
- Device Name
- DAXTON-K EUDAMED
- Model / Reference
- With needle(s) EUDAMEDXK1012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08698147930735 EUDAMED
- Basic UDI-DI
- 8698147S000XKW6 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
Daxton-K by Doğsan Tibbi̇ Malzeme Sanayi̇ A.ş. — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8698147S000XKW6 | Class III | Active |
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Manufacturer
- Manufacturer
- Doğsan Tibbi̇ Malzeme Sanayi̇ A.ş.
- EUDAMED SRN
- TR-MF-000016026
Sources (1)
- EUDAMED 85b7ca50-5104-4647-9852-e723bc1ff78f 61 fields · synced Jun 19, 2026