Identity
- Trade Name
- DAMADIOXANONE EUDAMED
- Device Name
- PDO,Monofilament, 4- 0, 16 mm, 3/8 keskin ,mor, emilebilir, 75 cm sütür EUDAMED
- Model / Reference
- DX4K16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-08681677076394XV EUDAMED
- Basic UDI-DI
- B-08681677076394XV EUDAMED
- EMDN Code
- H010101010101 POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR OPEN SURGERY EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Damadioxanone by Gmd Group Medi̇kal Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Polyester suture, bioabsorbable, monofilament, non-antimicrobial.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08681677076394XV | Class III | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000030794
Sources (1)
- EUDAMED 59cf1f7e-fab9-4423-b433-499a3436d79e 61 fields · synced Oct 7, 2026