Mendec Kypho Set Bilateral 15 mm
Ref ASB028B
Active
CE MDR
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/MDR | Number80314970703P7 08031497003788 | Date5 Mar 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Mendec Kypho Set Bilateral
- Model / Reference
- ASB028B
- Primary DI / UDI-DI
- 08031497003788
- Basic UDI-DI
- 80314970703P7
- EMDN Code
- P099002 Orthopaedic cement preparation and application devices and kits
- Device Class
- Class IIa
- Medical Purpose
- The overall intended purpose of Mendec Kypho Set is the creation of a void within vertebral body by a ballon catheter during percutaneous kyphoplasty (PKP) operation.
Manufacturer details
- EUDAMED SRN
- IT-PR-000027511