No Bubble TURP
Ref URO 005
No Bubble TURP (URO 005) is a medical device (EU MDR Class I; EMDN category irrigators) made by Wismed (PTY) Ltd, registered in EUDAMED on 24 Jul 2024 (Basic UDI-DI 60099004083URO00532), active as of 24 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number60099004083URO00532 06009900408347 | Date24 Jul 2024 | StatusActive |
Official records
- EUDAMED public site 60099004083URO00532
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / reference
- URO 005
- Primary DI / UDI-DI
- 06009900408347
- Basic UDI-DI
- 60099004083URO00532
- EMDN code
- Z12019007 Irrigators
- Device class
- Class I
- System or procedure pack
- System which is a device in itself
- EU registration type
- Standard device
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- ZA-MF-000035555
- Authorised representative
- TNMC Devices Llc HR-AR-000019582
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