Identity
- Trade Name
- SenSura Mio EUDAMED
- Device Name
- SenSura Mio High Output flex ostomy bag 2-piece EUDAMED
- Model / Reference
- 18655 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05708932047548 EUDAMED
- Basic UDI-DI
- 57089322976308T EUDAMED
- Unit of Use DI
- 05701780151719 EUDAMED
- EMDN Code
- A10020202 COLOSTOMY BAGS FOR TWO-PART SYSTEMS, WITH TISSUE COVER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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 | 57089322976308T | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Coloplast A/S
- EUDAMED SRN
- DK-MF-000025526
Sources (1)
- EUDAMED cf803b12-8acb-4625-a0b7-d4094c7b497a 61 fields · synced May 21, 2026