EasiCath
Ref 5362
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number57089322978169B | Date22 Jun 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- EasiCath urinary intermittent drainage catheter
- Model / Reference
- 5362
- Primary DI / UDI-DI
- 05701780842709, 05701780480475, 05701780478090, 05701780478069, 05701780490191, 05701780478137, 05701780547819, 05701780483940
- Basic UDI-DI
- 57089322978169B
- Unit of Use DI
- 05708932196857, 05701780187930, 05701780427098, 05701780427074, 05701780188005, 05701780187985, 05701780427081, 05701780188036
- EMDN Code
- U01010501 Nelaton catheters, self-lubricating
- Device Class
- Class I
- EU market of registration
- SpainLiechtensteinNorwayNetherlandsDenmarkItalyBelgiumIreland
Manufacturer details
- EUDAMED SRN
- DK-MF-000025526
Other devices from Coloplast A/S
Properties
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