Identity
- Trade Name
- Alterna EUDAMED
- Device Name
- Assura/Alterna (New Generation) ostomy bag 2-piece open EUDAMED
- Model / Reference
- 13985 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05708932384094 EUDAMED
- Basic UDI-DI
- 57089322975508U EUDAMED
- Unit of Use DI
- 05701780099721 EUDAMED
- EMDN Code
- A10020202,A10020302 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Hungary 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 | 57089322975508U | Class I | Active |
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Manufacturer
- Manufacturer
- Coloplast A/S
- EUDAMED SRN
- DK-MF-000025526
Sources (1)
- EUDAMED ba5fcaa0-1b61-4d6c-b986-b54773d94c33 61 fields · synced May 29, 2026