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Tahina 0.018" Ureteroscopy Balloon Dilator
EUDAMEDClass IIa (EU MDR)
Ref UDB-0205040SModel Tahina 0.018" Ureteroscopy Balloon Dilator
by Envaste Ltd
Identity
- Trade Name
- Tahina 0.018" Ureteroscopy Balloon Dilator EUDAMED
- Device Name
- Tahina 0.018" Ureteroscopy Balloon Dilator EUDAMED
- Model / Reference
- Tahina 0.018" Ureteroscopy Balloon Dilator EUDAMEDUDB-0205040S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 60913190405390 EUDAMED
- Basic UDI-DI
- 60913190UDB-029E EUDAMED
- EMDN Code
- U030202 URETERAL DILATORS, WITH BALLOON EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
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
Tahina 0.018" Ureteroscopy Balloon Dilator by Envaste Ltd — Class IIa — 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 | 60913190UDB-029E | Class IIa | Active |
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Manufacturer
- Manufacturer
- Envaste Ltd
- EUDAMED SRN
- MU-MF-000030801
- Authorised Representative
- ENVASTE LTD IE-AR-000028866
Sources (1)
- EUDAMED 4d938dbd-d815-40d8-8de8-b35dfbefe051 61 fields · synced Jun 18, 2026