Identity
- Trade Name
- DAXTON-D EUDAMED
- Device Name
- DAXTON-D EUDAMED
- Model / Reference
- With needle(s) EUDAMEDXD5193 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08698147931084 EUDAMED
- Basic UDI-DI
- 8698147S000XDVQ 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-D by Doğsan Tibbi̇ Malzeme Sanayi̇ A.ş. — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Polyolefin/fluoropolymer suture, monofilament.
- SUTUMED — Unilene Sac · Class II
- DemeLENE — DemeTECH Corp · Class II
- DemeLENE — DemeTECH Corp · Class II
- ATRAMAT — Internacional Farmacéutica S.A DE C.V · Class II
- DemeLENE — DemeTECH Corp · Class II
- WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc. · Class II
- Premilene — B BRAUN SURGICAL SA · Class II
- DEKNATEL — TELEFLEX INCORPORATED · Class II
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 | 8698147S000XDVQ | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Doğsan Tibbi̇ Malzeme Sanayi̇ A.ş.
- EUDAMED SRN
- TR-MF-000016026
Sources (1)
- EUDAMED 251675b1-5905-4306-9ec5-e4d0a29b3674 61 fields · synced Jun 19, 2026