Identity
- Trade Name
- Assura EUDAMED
- Device Name
- Assura/Alterna (New Generation) ostomy bag 1-piece open EUDAMED
- Model / Reference
- 138500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05701780783415 EUDAMED
- Basic UDI-DI
- 570893229754899 EUDAMED
- Unit of Use DI
- 05701780095488 EUDAMED
- EMDN Code
- A1001010102,A1001020102 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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 | 570893229754899 | Class I | Active |
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Manufacturer
- Manufacturer
- Coloplast A/S
- EUDAMED SRN
- DK-MF-000025526
Sources (1)
- EUDAMED 74ae47b7-6f6b-4608-a385-6bec97438153 61 fields · synced May 21, 2026