Ostoform FLOWASSIST Convex Baseplate
by Ostoform Limited Ireland EUDAMED
Ref OFA-CB57-M EMDN A1002010402
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number539153622OFA-CB78 | Date12 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- OFA-CB57-M
- Primary DI / UDI-DI
- 05391536221614
- Basic UDI-DI
- 539153622OFA-CB78
- Unit of Use DI
- 05391536221607
- EMDN Code
- A1002010402 Universal plates for abdominal stoma (colo-, ileo-, urostomy) with 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 Convex 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 (1)
- EUDAMED 05391536221614|539153622OFA-CB78