Identity
- Trade Name
- SenSura Mio Concave EUDAMEDSenSura Mio Convex Flip FDA UDI
- Generic Name
- One-piece intestinal ostomy bag, closed-ended FDA UDI
- Device Name
- SenSura Mio Concave ostomy bag 1-piece closed EUDAMED
- Model / Reference
- 18182 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 18182 FDA UDI
- Primary DI / UDI-DI
- 05708932040938 EUDAMED05708932114363 FDA UDI
- Basic UDI-DI
- 57089322975098X EUDAMED
- Unit of Use DI
- 05708932042147 EUDAMED
- FDA Product Code
- EXB FDA UDI
- EMDN Code
- A1001010202 ONE-PIECE COLOSTOMY BAGS FOR RETRACTED STOMA, CONVEX, WITH TISSUE COVER EUDAMED
- GMDN Term
- One-piece intestinal ostomy bag, closed-ended FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.5900 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: One-piece intestinal ostomy bag, closed-ended
SenSura Mio Convex Flip by Coloplast A/S — Class I — MDR, FDA UDI — listed in FDA GUDID, 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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Coloplast A/S
Sources (2)
- FDA UDI b6af780e-b151-4af6-8cde-6e8a3b19a0da 35 fields · synced Jul 9, 2026
- EUDAMED 85ade265-739a-45b6-8369-f54dea70c5c9 61 fields · synced Jul 9, 2026