Identity
- Trade Name
- SenSura Mio EUDAMED
- Device Name
- SenSura Mio High Output ostomy bag 1-piece EUDAMED
- Model / Reference
- 186610 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05708932065641 EUDAMED
- Basic UDI-DI
- 570893229762796 EUDAMED
- Unit of Use DI
- 05701780152099 EUDAMED
- EMDN Code
- A1001020102 ONE-PIECE ILEOSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT, WITH TISSUE COVER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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 | 570893229762796 | Class I | Active |
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Manufacturer
- Manufacturer
- Coloplast A/S
- EUDAMED SRN
- DK-MF-000025526
Sources (1)
- EUDAMED 72e4c006-1bd5-4931-9b72-f42dda78395e 61 fields · synced May 21, 2026