Identity
- Trade Name
- Assura EUDAMED
- Device Name
- Assura/Alterna (Original) urostomy bag 1-piece convex EUDAMED
- Model / Reference
- 12996 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05701780566339 EUDAMED
- Basic UDI-DI
- 57089322975779G EUDAMED
- Unit of Use DI
- 05701780091831 EUDAMED
- EMDN Code
- A1001030202 ONE-PIECE UROSTOMY BAGS FOR RETRACTED STOMA, CONVEX, WITH TISSUE COVER 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 | 57089322975779G | Class I | Active |
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Manufacturer
- Manufacturer
- Coloplast A/S
- EUDAMED SRN
- DK-MF-000025526
Sources (1)
- EUDAMED 170dd3e7-3a62-4c8c-8098-28a64bc88b70 61 fields · synced May 23, 2026