Identity
- Trade Name
- SenSura Mio EUDAMED
- Device Name
- SenSura Mio flex ostomy bag 2-piece open EUDAMED
- Model / Reference
- 11964 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05708932930246 EUDAMED
- Basic UDI-DI
- 570893229753794 EUDAMED
- Unit of Use DI
- 05708932931038 EUDAMED
- EMDN Code
- A10020302 ILEOSTOMY BAGS FOR TWO-PART SYSTEMS, WITH TISSUE COVER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland 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
SenSura Mio 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 | 570893229753794 | Class I | Active |
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Manufacturer
- Manufacturer
- Coloplast A/S
- EUDAMED SRN
- DK-MF-000025526
Sources (1)
- EUDAMED 1b9f7bb6-fce7-48fa-82b9-f4409d5dc7db 61 fields · synced May 22, 2026