Identity
- Trade Name
- VERTEBROPLASTIC EUDAMED
- Device Name
- VERTEBROPLASTIC EUDAMEDVERTEBROPLASTY SYSTEMS EUDAMED
- Model / Reference
- KRVT1515200CBP-A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860030742 EUDAMED
- Basic UDI-DI
- B-08033860030742 EUDAMED8033860VERTFT05CL 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 — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08033860030742 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08033860030742 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (2)
- EUDAMED bd771f77-0b1a-4686-b638-d56266f7d237 61 fields · synced Jun 19, 2026
- EUDAMED b043d5f9-a907-4f2b-9e32-ea27cf4a03d6 61 fields · synced May 19, 2026