FLOWASSIST Seal
by Ostoform Limited Ireland EUDAMED
Ref OFA-L, OFA-S EMDN A108001
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number539153622OFAKP | Date18 Jan 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- OFA-L, OFA-S
- Primary DI / UDI-DI
- 05391536220389, 05391536220341
- Basic UDI-DI
- 539153622OFAKP
- Unit of Use DI
- 05391536220334, 05391536220310
- EMDN Code
- A108001 Rings / bezels / plates for peristomal skin
- Device Class
- Class I
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- IE-MF-000014357
From the manufacturer
Manufacturer's product page: FLOWASSIST Seal
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 24d286e9-3676-46fa-b8c1-0fa3cb91f013
- EUDAMED 05391536220341|539153622OFAKP