Kyphoset Working Cannula and Diamond Tip
Ref 11KSDIAMOND
Active
CE MDR
Valid until
14 Jun 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberIT353495 | Date4 Sep 2026 | StatusActive |
Certificates
- IT353495 Active
Quality management system EU MDR
- Certifier
- BUREAU VERITAS ITALIA S.P.A. 1370
- Issued
- 4 Sep 2026
- Expires
- 14 Jun 2031
- Reason
- Other
- IT349638 Withdrawn
Quality assurance EU MDR
- Certifier
- BUREAU VERITAS ITALIA S.P.A. 1370
- Issued
- 10 Feb 2026
- Expires
- 9 Feb 2030
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Kyphoplasty Systems
- Model / Reference
- 11KSDIAMOND
- Primary DI / UDI-DI
- 08033860050184
- Basic UDI-DI
- 8033860KYPFT05A9T
- EMDN Code
- K010301 Spinal percutaneous plastic devices with balloon
- Device Class
- Class IIa
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000011601
Other devices from Biopsybell SRL
Properties
Other properties (12)
- 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