Identity
- Trade Name
- Alterna EUDAMED
- Device Name
- Assura/Alterna (Original) urostomy bag 1-piece EUDAMED
- Model / Reference
- 5575 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05701780088602 EUDAMED
- Basic UDI-DI
- 57089322975769E EUDAMED
- Unit of Use DI
- 05701780031127 EUDAMED
- EMDN Code
- A1001030102 ONE-PIECE UROSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT, WITH TISSUE COVER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Alterna by Coloplast A/S — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 57089322975769E | Class I | Active |
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Manufacturer
- Manufacturer
- Coloplast A/S
- EUDAMED SRN
- DK-MF-000025526
Sources (1)
- EUDAMED 0a2ecfc4-9bb0-41fa-9a94-6b01ccaf7be9 61 fields · synced May 29, 2026