Identity
- Trade Name
- SenSura Mio Concave EUDAMED
- Device Name
- SenSura Mio Concave ostomy bag 1-piece closed EUDAMED
- Model / Reference
- 18185 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05708932040945 EUDAMED
- Basic UDI-DI
- 57089322975098X EUDAMED
- Unit of Use DI
- 05708932042154 EUDAMED
- EMDN Code
- A1001010201 ONE-PIECE COLOSTOMY BAGS FOR RETRACTED STOMA, CONVEX, W/O TISSUE COVER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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 Concave 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 | 57089322975098X | Class I | Active |
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Manufacturer
- Manufacturer
- Coloplast A/S
- EUDAMED SRN
- DK-MF-000025526
Sources (1)
- EUDAMED fd0a125f-128e-4630-a375-0b90b593d494 61 fields · synced Jun 19, 2026