Identity
- Trade Name
- SenSura Mio Concave EUDAMED
- Device Name
- SenSura Mio Concave urostomy bag 1-piece EUDAMED
- Model / Reference
- 18401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05708932113991 EUDAMED
- Basic UDI-DI
- 570893229757194 EUDAMED
- Unit of Use DI
- 05701780146814 EUDAMED
- EMDN Code
- A100199 DEVICES FOR ABDOMINAL OSTOMY - ONE PIECE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Liechtenstein 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 | 570893229757194 | Class I | Active |
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Manufacturer
- Manufacturer
- Coloplast A/S
- EUDAMED SRN
- DK-MF-000025526
Sources (1)
- EUDAMED 570e2740-ab93-4763-8b67-8bba2a577e95 61 fields · synced Jul 31, 2026