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Tahina 0.038" Nephrostomy Balloon Dilator
EUDAMEDClass IIa (EU MDR)
Ref UDB-0308120SModel Tahina 0.038" Nephrostomy Balloon Dilator
by Envaste Ltd
Identity
- Trade Name
- Tahina 0.038" Nephrostomy Balloon Dilator EUDAMED
- Device Name
- Tahina 0.038" Nephrostomy Balloon Dilator EUDAMED
- Model / Reference
- Tahina 0.038" Nephrostomy Balloon Dilator EUDAMEDUDB-0308120S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 60913190405468 EUDAMED
- Basic UDI-DI
- 60913190UDB-039G EUDAMED
- EMDN Code
- U0399 DEVICES FOR URINARY TRACT DILATION - OTHER 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 0.038" Nephrostomy 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-039G | 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 625a5dcb-716f-4f70-bbf4-0f5713b2a6f6 61 fields · synced Jul 15, 2026