Identity
- Trade Name
- Alterna EUDAMED
- Device Name
- Assura/Alterna (Original) ostomy bag 1-piece open EUDAMED
- Model / Reference
- 12680 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05708932732628 EUDAMED
- Basic UDI-DI
- 570893229754593 EUDAMED
- Unit of Use DI
- 05701780422741 EUDAMED
- EMDN Code
- A1001010102,A1001020102 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Bulgaria 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 | 570893229754593 | Class I | Active |
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Manufacturer
- Manufacturer
- Coloplast A/S
- EUDAMED SRN
- DK-MF-000025526
Sources (1)
- EUDAMED b8e3bbdf-4927-4205-9c58-77e2d0d19310 61 fields · synced May 29, 2026