Identity
- Trade Name
- Alterna Confort EUDAMED
- Device Name
- Alterna (Upgrade Original) ostomy bag closed and baseplate minicap (set 2-piece) EUDAMED
- Model / Reference
- 17991 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05708932888929 EUDAMED
- Basic UDI-DI
- 57089329103457B EUDAMED
- EMDN Code
- A1002010401,A10020202,A10020302 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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 Confort 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 | 57089329103457B | Class I | Active |
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Manufacturer
- Manufacturer
- Coloplast A/S
- EUDAMED SRN
- DK-MF-000025526
Sources (1)
- EUDAMED 037658e1-f1ec-4f7d-ae58-85a785fb136f 61 fields · synced Jun 19, 2026