CeraFlex
by LifeTech Scientific (Europe) B.V. 42 variants
Ref LE-PDAf-0406
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-08720214005678 08720214005678 | Date2 Aug 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device Name
- CeraFlex™ PDA Closure System
- Model / Reference
- LE-PDAf-0406
- Primary DI / UDI-DI
- 08720214005678
- Basic UDI-DI
- B-08720214005678
- EMDN Code
- P07040303 Cardiac occluders, foramen ovale and botallo duct
- Device Class
- Class III
- EU market of registration
- Denmark
Manufacturer details
- EUDAMED SRN
- NL-MF-000005742
Other devices from LifeTech Scientific (Europe) B.V.
Properties
Other properties (9)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No