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Renova Spine Fast Access System
EUDAMEDClass IIa (EU MDR)
Ref RES1112002VBRef RESTR1112002VRef RES1212001V
Identity
- Trade Name
- RENOVA SPINE FAST ACCESS SYSTEM EUDAMED
- Device Name
- KYPHOPLASTY SYSTEMS EUDAMEDRENOVA SPINE FAST ACCESS SYSTEM EUDAMED
- Model / Reference
- RES1112002VB EUDAMEDRESTR1112002V EUDAMEDRES1212001V EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860024253 EUDAMED08033860026547 EUDAMED08033860019242 EUDAMED
- Basic UDI-DI
- 8033860KYPFT05A9T EUDAMEDB-08033860019242 EUDAMEDB-08033860026547 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 Fast Access System 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 (5)
- EUDAMED a11ef69a-43cc-4ab5-9a2a-27827f38845e 61 fields · synced Jul 29, 2026
- EUDAMED 894c3fa5-05c9-4b95-b62d-2f7ec1c8a52d 61 fields · synced May 17, 2026
- EUDAMED 52f33dcd-3925-4c08-b5ef-407cb5c94047 61 fields · synced May 17, 2026
- EUDAMED 26ed5787-e937-49eb-976a-1ace8405e820 61 fields · synced Jul 9, 2026
- EUDAMED 955adf68-fee7-4ff5-a2c5-f30072423670 61 fields · synced Jul 29, 2026