Identity
- Trade Name
- Coloplast EUDAMED
- Generic Name
- UROSTOMY BAGS FOR TWO-PART SYSTEMS, WITH TISSUE COVER EUDAMED
- Device Name
- Assura/Alterna/Coloplast (Original) urostomy 2-piece minicap EUDAMED
- Model / Reference
- 2807 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05701780856980 EUDAMED
- Basic UDI-DI
- 57089322975799L EUDAMED
- Unit of Use DI
- 05701780024457 EUDAMED
- EMDN Code
- A10020402 UROSTOMY BAGS FOR TWO-PART SYSTEMS, WITH TISSUE COVER EUDAMED
Classification
- Legislation / Framework
- MDR (REGULATION (EU) 2017/745 on medical devices) EUDAMED
- Market of Registration
- Italy 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
Coloplast by Coloplast A/S (urostomy bags for two-part systems, with tissue cover) — 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 | 57089322975799L | Class I | Active |
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Manufacturer
- Manufacturer
- Coloplast A/S
- EUDAMED SRN
- DK-MF-000025526
Sources (1)
- EUDAMED 68 fields · synced May 23, 2026