Ostoform FLOWASSIST Flat Baseplate
by Ostoform Limited Ireland EUDAMED
Ref OFA-FB57-M EMDN A1002010401
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number539153622OFA-FB7H | Date12 Jun 2026 | StatusWithdrawn |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Withdrawn
Specification
- Model / Reference
- OFA-FB57-M
- Primary DI / UDI-DI
- 05391536220686, 05391536221522
- Basic UDI-DI
- 539153622OFA-FB7H
- Unit of Use DI
- 05391536220679, 05391536221515
- EMDN Code
- A1002010401 Universal plates for abdominal stoma (colo-, ileo-, urostomy) with non-introflex stoma
- Device Class
- Class I
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- IE-MF-000014357
From the manufacturer
Manufacturer's product page: FLOWASSIST Flat Cut-to-Fit Baseplate $49.99
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 (2)
- EUDAMED 01a348a9-348d-4f48-ba0e-01d82d87c901
- EUDAMED 05391536221522|539153622OFA-FB7H