Identity
- Trade Name
- VERTEBROPLASTIC EUDAMED
- Device Name
- VERTEBROPLASTY SYSTEMS EUDAMEDVERTEBROPLASTIC EUDAMED
- Model / Reference
- KRVT1310200CBP-A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860029661 EUDAMED
- Basic UDI-DI
- 8033860VERTFT05CL EUDAMEDB-08033860029661 EUDAMED
- EMDN Code
- A019011 INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Vertebroplastic by Biopsybell Srl — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 8033860VERTFT05CL | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8033860VERTFT05CL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (2)
- EUDAMED 589a333f-4416-4a4e-a7c3-0e110ea87599 61 fields · synced Jul 23, 2026
- EUDAMED e475c31c-3a0c-4a7d-ac76-a87f6cc54368 61 fields · synced May 19, 2026