Ostoform Moldable Seal with FLOWASSIST Protection
by Ostoform Limited EUDAMED
Withdrawn
Ref OFA-L
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number539153622OFAKP | Date18 Jan 2024 | StatusWithdrawn |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Withdrawn
Specification
- Device Name
- FLOWASSIST Seal
- Model / Reference
- OFA-L
- Primary DI / UDI-DI
- 05391536220105
- Basic UDI-DI
- 539153622OFAKP
- Unit of Use DI
- 05391536220075
- EMDN Code
- A108001 Rings / bezels / plates for peristomal skin
- Device Class
- Class I
Manufacturer details
- EUDAMED SRN
- IE-MF-000014357
From the manufacturer
Manufacturer's product page: FLOWASSIST Seal
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