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Dexell Vur
EUDAMEDClass III (EU MDR)
Ref DXL-5010Model DEXELL VUR, Sterile Injectable Implant for the Treatment of Vesicoureteral Reflux (VUR)
by İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi
Identity
- Trade Name
- DEXELL VUR EUDAMED
- Device Name
- DEXELL VUR, Sterile Injectable Implant for the Treatment of Vesicoureteral Reflux (VUR) EUDAMED
- Model / Reference
- DEXELL VUR, Sterile Injectable Implant for the Treatment of Vesicoureteral Reflux (VUR) EUDAMEDDXL-5010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08698703339453 EUDAMED
- Basic UDI-DI
- B-08698703339453 EUDAMED
- EMDN Code
- U090399 SINGLE-USE INSTRUMENTS FOR UROGENITAL ENDOSCOPY - OTHER 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
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
Dexell Vur by İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi — 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-08698703339453 | Class III | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000017811
Sources (1)
- EUDAMED 4f17741e-a6bf-4edd-a031-5c5945ac0835 61 fields · synced Oct 7, 2026