Identity
- Trade Name
- Assura EUDAMED
- Device Name
- Assura/Alterna (New Generation) ostomy bag 2-piece closed EUDAMED
- Model / Reference
- 12375 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05701780732796 EUDAMED
- Basic UDI-DI
- 57089322975228P EUDAMED
- Unit of Use DI
- 05701780086318 EUDAMED
- EMDN Code
- A10020202,A10020302 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Assura 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 | 57089322975228P | Class I | Active |
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Manufacturer
- Manufacturer
- Coloplast A/S
- EUDAMED SRN
- DK-MF-000025526
Sources (1)
- EUDAMED c2f1e7db-b764-4a71-8b13-cdbd3f9c0680 61 fields · synced May 21, 2026