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Renova Spine Classic Access System
EUDAMEDClass IIa (EU MDR)
Ref RES1112001LRef RES1112002L
Identity
- Trade Name
- RENOVA SPINE CLASSIC ACCESS SYSTEM EUDAMED
- Device Name
- KYPHOPLASTY SYSTEMS EUDAMEDRENOVA SPINE CLASSIC ACCESS SYSTEM EUDAMED
- Model / Reference
- RES1112001L EUDAMEDRES1112002L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860018801 EUDAMED08033860018788 EUDAMED
- Basic UDI-DI
- 8033860KYPFT05A9T EUDAMEDB-08033860018788 EUDAMEDB-08033860018801 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 Classic 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 (4)
- EUDAMED 0132576c-320e-4584-a264-f1080c8204a7 61 fields · synced Jul 21, 2026
- EUDAMED 74015782-6fc8-47e9-90bd-dfd2e8037325 61 fields · synced May 17, 2026
- EUDAMED b2f5e897-75b6-407f-b458-79a4f9d98d63 61 fields · synced Jun 18, 2026
- EUDAMED 07636e94-ba94-42f9-9c9c-265b06c8508d 61 fields · synced Jul 14, 2026