Identity
- Trade Name
- VERT-PLASTY EUDAMED
- Device Name
- VERTEBROPLASTY SYSTEMS EUDAMED
- Model / Reference
- VKR-1512 EUDAMEDVKR-1115 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860040345 EUDAMED08033860045401 EUDAMED
- Basic UDI-DI
- 8033860VERTFT05CL 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
Vert-Plasty by Biopsybell Srl — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 7b4d38ea-5da1-4059-ad4c-ae580a9cd39a 61 fields · synced Sep 17, 2026
- EUDAMED 3621301c-bbc4-4e90-806b-c72890efe059 61 fields · synced May 18, 2026