Assura
by Coloplast A/S Denmark EUDAMED
Ref 5580
EMDN A1001030102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number57089322975769E | Date5 Dec 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Trade Name
- AssuraAlterna
- Device Name
- Assura/Alterna (Original) urostomy bag 1-piece
- Model / Reference
- 5580
- Primary DI / UDI-DI
- 05701780840842, 05701780820974, 05701780840804, 05708932191616, 05701780911245, 05701780845151
- Basic UDI-DI
- 57089322975769E
- Unit of Use DI
- 05701780031608, 05701780031448, 05708932965279, 05701780031592, 05701780031394, 05701780031165
- EMDN Code
- A1001030102 One-piece urostomy bags for non-retracted stoma, flat, with tissue cover
- Device Class
- Class I
- Market of Registration
- LiechtensteinDenmarkGermanyRomaniaCroatiaNetherlands
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 (13)
- Sterile: No
- 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 (6)
- EUDAMED 63b6d5a9-0e46-46cd-8c3c-fc184d7f3f69
- EUDAMED 05701780820974|57089322975769E
- EUDAMED 05701780840804|57089322975769E
- EUDAMED 05708932191616|57089322975769E
- EUDAMED 05701780911245|57089322975769E
- EUDAMED 05701780845151|57089322975769E