Identity
- Trade Name
- DAMALENE EUDAMED
- Device Name
- PP MONOFILAMENT EMİLEMEYEN SÜTÜR 75cm 5-0 MAVİ 12mm 3/8 DAİRE TERS KESKİN İĞNE EUDAMED
- Model / Reference
- DE50DS12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-08681677083453XA EUDAMED
- Basic UDI-DI
- B-08681677083453XA EUDAMED
- EMDN Code
- H010201010401 POLYPROPYLENE 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
Damalene by Gmd Group Medi̇kal Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-08681677083453XA | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- TR-MF-000030794
Sources (1)
- EUDAMED f7903e3e-c1f7-4b04-993b-ddf2e9cb3e38 61 fields · synced Oct 8, 2026