Identity
- Trade Name
- RENOVA SPINE FAST ACCESS SYSTEM EUDAMED
- Device Name
- RENOVA SPINE FAST ACCESS SYSTEM EUDAMED
- Model / Reference
- RES1112002VB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860024277 EUDAMED
- Basic UDI-DI
- B-08033860024277 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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 — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08033860024277 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (1)
- EUDAMED 738da5da-1467-4c63-9ea0-30e93856e706 61 fields · synced Jun 18, 2026