Identity
- Trade Name
- SenSura Mio FDA UDI
- Generic Name
- Colostomy irrigation sleeve FDA UDI
- Model / Reference
- 11750 FDA UDI
Identifiers
- Catalog Number
- 11750 FDA UDI
- Primary DI / UDI-DI
- 05708932749961 FDA UDI
- FDA Product Code
- EXD FDA UDI
- GMDN Term
- Colostomy irrigation sleeve FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5895 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
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
Category: Colostomy irrigation sleeve
SenSura Mio by Coloplast A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Colostomy irrigation sleeve.
- Coloplast — Coloplast A/S · Class II
- Assura — Coloplast A/S · Class II
- SenSura Mio — Coloplast A/S · Class II
- Assura — Coloplast A/S · Class II
- Assura — Coloplast A/S · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Coloplast A/S
Sources (1)
- FDA UDI bcb45901-ab19-4288-a090-ab5a4e9f5684 34 fields · synced May 31, 2026