Identity
- Trade Name
- SenSura Mio Concave EUDAMEDSenSura Mio Convex Flip FDA UDI
- Generic Name
- One-piece urostomy bag, open-ended FDA UDI
- Device Name
- SenSura Mio Concave urostomy bag 1-piece EUDAMED
- Model / Reference
- 18401 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 18401 FDA UDI
- Primary DI / UDI-DI
- 05701780454797 EUDAMED05708932114585 FDA UDI
- Basic UDI-DI
- 570893229757194 EUDAMED
- Unit of Use DI
- 05701780454810 EUDAMED
- FDA Product Code
- EXB FDA UDI
- EMDN Code
- A100199 DEVICES FOR ABDOMINAL OSTOMY - ONE PIECE - OTHER EUDAMED
- GMDN Term
- One-piece urostomy bag, open-ended FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.5900 FDA UDI
- Market of Registration
- Denmark 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 urostomy bag, open-ended
SenSura Mio Convex Flip by Coloplast A/S — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Coloplast A/S
Sources (2)
- FDA UDI 7d5c5a06-96fd-434a-8c96-57d52502690d 35 fields · synced Jun 18, 2026
- EUDAMED c652113a-56a8-44b6-8e74-f26184025dea 61 fields · synced Jun 18, 2026