Identity
- Trade Name
- SenSura Mio Concave EUDAMED
- Device Name
- SenSura Mio Concave ostomy bag 1-piece closed EUDAMED
- Model / Reference
- 181010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05708932036405 EUDAMED
- Basic UDI-DI
- 57089322975098X EUDAMED
- Unit of Use DI
- 05701780143011 EUDAMED
- EMDN Code
- A1001010202 ONE-PIECE COLOSTOMY BAGS FOR RETRACTED STOMA, CONVEX, WITH TISSUE COVER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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
Category: One-piece intestinal ostomy bag, closed-ended
SenSura Mio Concave by Coloplast A/S — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as One-piece intestinal ostomy bag, closed-ended.
- Hollister — Hollister Incorporated · Class I
- Hollister — Hollister Incorporated · Class I
- Dansac — Dansac A/S · Class I
- Hollister — Hollister Incorporated · Class I
- Dansac — Dansac A/S · Class I
- Dansac — Dansac A/S · Class I
- ESTEEM — CONVATEC, PURCHASING DEPARTMENT · Class I
- Dansac — Dansac A/S · Class I
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 8dfcf361-2ba2-40a8-9101-efcc66b52484 61 fields · synced Jun 12, 2026