Ostoform FLOWASSIST Drainable Pouch
by Ostoform Limited Ireland EUDAMED
Ref OFA-DP57 EMDN A10020302
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number539153622OFA-DP87 | Date20 Apr 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- OFA-DP57
- Primary DI / UDI-DI
- 05391536220778, 05391536220532, 05391536221676
- Basic UDI-DI
- 539153622OFA-DP87
- Unit of Use DI
- 05391536220761, 05391536220525, 05391536221669
- EMDN Code
- A10020302 Ileostomy bags for two-part systems, with tissue cover
- Device Class
- Class I
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- IE-MF-000014357
From the manufacturer
Manufacturer's product page: FLOWASSIST Drainable 2-Piece Pouch $39.95
Other devices from Ostoform Limited
Properties & raw data
Show properties, registry sources and raw records
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
Sources (3)
- EUDAMED cd517276-ca41-4308-bcf4-71a5de3056b0
- EUDAMED 05391536220532|539153622OFA-DP87
- EUDAMED 05391536221676|539153622OFA-DP87