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Renova Spine Kyphoplasty Working Cannula And Diamond Tip
EUDAMEDClass IIa (EU MDR)
Ref RESWD1112C
Identity
- Trade Name
- RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND DIAMOND TIP EUDAMED
- Device Name
- KYPHOPLASTY SYSTEMS EUDAMEDRENOVA SPINE KYPHOPLASTY WORKING CANNULA AND DIAMOND TIP EUDAMED
- Model / Reference
- RESWD1112C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860019082 EUDAMED
- Basic UDI-DI
- 8033860KYPFT05A9T EUDAMEDB-08033860019082 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 Diamond 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 9dda3f93-86ca-4b86-8415-417ff03497bd 61 fields · synced Jul 21, 2026
- EUDAMED 0292a2d2-a74f-4bc7-be99-92e4d39f0080 61 fields · synced May 19, 2026