Identity
- Trade Name
- No Bubble TURP EUDAMED
- Device Name
- No Bubble TURP EUDAMED
- Model / Reference
- URO 005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06009900408347 EUDAMED
- Basic UDI-DI
- 60099004083URO00532 EUDAMED
- EMDN Code
- Z12019007 IRRIGATORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
No Bubble TURP by Wismed (PTY) Ltd — Class I — 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 | 60099004083URO00532 | Class I | Active |
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Manufacturer
- Manufacturer
- Wismed (PTY) Ltd
- EUDAMED SRN
- ZA-MF-000035555
- Authorised Representative
- TNMC Devices Llc HR-AR-000019582
Sources (1)
- EUDAMED 5142f2bf-9253-4615-be1e-52f00fd9f2a3 61 fields · synced Jul 24, 2026