BoNee
by Coloplast A/S Denmark EUDAMED
Ref BBI035
EMDN A019099
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number570893263588694 | Date19 Aug 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Bonee needle for bladder injection
- Model / Reference
- BBI035
- Primary DI / UDI-DI
- 03600040281536
- Basic UDI-DI
- 570893263588694
- EMDN Code
- A019099 Needles for other procedures - other
- Device Class
- Class IIa
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- DK-MF-000025526
Other devices from Coloplast A/S
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 03600040281536|570893263588694