Identity
- Trade Name
- SenSura Mio Concave EUDAMED
- Device Name
- SenSura Mio Concave ostomy bag 1-piece open EUDAMED
- Model / Reference
- 18202 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05708932112727 EUDAMED
- Basic UDI-DI
- 57089322975408R EUDAMED
- Unit of Use DI
- 05701780144681 EUDAMED
- EMDN Code
- A100199 DEVICES FOR ABDOMINAL OSTOMY - ONE PIECE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia 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 | 57089322975408R | Class I | Active |
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Manufacturer
- Manufacturer
- Coloplast A/S
- EUDAMED SRN
- DK-MF-000025526
Sources (1)
- EUDAMED 44cb2064-13ca-4fff-b734-2ebe7e4be75f 61 fields · synced Jul 20, 2026