Ostoform FLOWASSIST Convex Urostomy Pouch
by Ostoform Limited EUDAMED
Active
Ref OFA-10012-S
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number539153622OFA-1CBUPQN | Date10 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- OFA-10012-S
- Primary DI / UDI-DI
- 05391536222123
- Basic UDI-DI
- 539153622OFA-1CBUPQN
- Unit of Use DI
- 05391536222093
- EMDN Code
- A1001030202 One-piece urostomy bags for retracted stoma, convex, with tissue cover
- Device Class
- Class I
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- IE-MF-000014357
From the manufacturer
Manufacturer's product page: FLOWASSIST Urostomy 2-Piece Pouch $39.95
Other devices from Ostoform Limited
Properties
Show properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No