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Renova Spine Kyphoplasty Working Cannula And Bevel/Trocar Tip
EUDAMEDClass IIa (EU MDR)
Ref RESW1112.5BV
Identity
- Trade Name
- RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND BEVEL/TROCAR TIP EUDAMEDRENOVA SPINE KYPHOPLASTY WORKING CANNULA AND BEVEL TIP EUDAMED
- Device Name
- KYPHOPLASTY SYSTEMS EUDAMEDRENOVA SPINE KYPHOPLASTY WORKING CANNULA AND BEVEL TIP EUDAMED
- Model / Reference
- RESW1112.5BV EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860013974 EUDAMED
- Basic UDI-DI
- 8033860KYPFT05A9T EUDAMEDB-08033860013974 EUDAMED
- EMDN Code
- K010301 SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON 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
Renova Spine Kyphoplasty Working Cannula And Bevel/Trocar Tip 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 | 8033860KYPFT05A9T | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8033860KYPFT05A9T | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (2)
- EUDAMED 9540d142-5c43-42a3-a3bf-e20f5f6f1bad 61 fields · synced Oct 6, 2026
- EUDAMED 5b1ce5ce-e9d2-48ec-b58e-2d8bd8eb5e04 61 fields · synced May 18, 2026