Rti-V
Ref RTI-VG1112
Active
CE MDR CE MDD
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 |
| European Union | CE/MDD | Number8033860VERTFT05CL 08033860031015 | Date20 Jan 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- IT349638 Withdrawn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- Withdrawn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/MDD, CE/MDR Active
Specification
- Device Name
- Vertebroplasty Systems
- Model / Reference
- RTI-VG1112
- Primary DI / UDI-DI
- 08033860031015
- Basic UDI-DI
- 8033860VERTFT05CL, B-08033860031015
- EMDN Code
- A019011 Intraosseous infusion and vertebroplasty infusion needles and kits
- 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