Identity
- Trade Name
- SenSura Mio Convex EUDAMEDFDA UDI
- Generic Name
- One-piece intestinal ostomy bag, closed-ended FDA UDI
- Device Name
- SenSura Mio Convex ostomy bag 1-piece closed EUDAMED
- Model / Reference
- 19579 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 19579 FDA UDI
- Primary DI / UDI-DI
- 05701780369350 EUDAMED05701780361309 FDA UDI
- Basic UDI-DI
- 57089322975088V EUDAMED
- Unit of Use DI
- 05701780369374 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 by Coloplast A/S — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as One-piece intestinal ostomy bag, closed-ended.
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- Dansac — Dansac A/S · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 57089322975088V | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Coloplast A/S
- EUDAMED SRN
- DK-MF-000025526
Sources (2)
- EUDAMED d8d22052-0034-4e0d-adf7-35f4fe58fd8d 61 fields · synced Jul 15, 2026
- FDA UDI 2c8acb18-b5df-47c6-805a-bc05276ee74b 36 fields · synced May 30, 2026