Assura
by Coloplast A/S Denmark EUDAMED
Ref 14225
EMDN A10020402
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number57089322975839B | Date10 Dec 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Trade Name
- AssuraAlterna
- Device Name
- Assura/Alterna (New Generation) urostomy bag 2-piece
- Model / Reference
- 14225
- Primary DI / UDI-DI
- 05701780983778, 05708932142557, 05701780877237, 05701780749336, 05701780830638, 05708932169103
- Basic UDI-DI
- 57089322975839B
- Unit of Use DI
- 05701780104937, 05701780105057, 05701780104913, 05708932961424, 05701780105088, 05701780104890
- EMDN Code
- A10020402 Urostomy bags for two-part systems, with tissue cover
- Device Class
- Class I
- Market of Registration
- DenmarkIrelandNetherlandsGermanyLiechtensteinItaly
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 a4bc86e7-8997-4327-b329-28d9fba18a96
- EUDAMED 05708932142557|57089322975839B
- EUDAMED 05701780877237|57089322975839B
- EUDAMED 05701780749336|57089322975839B
- EUDAMED 05701780830638|57089322975839B
- EUDAMED 05708932169103|57089322975839B