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Renova Spine Balloon Catheter
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref RESB10VMRef RESB20VMRef RESB15VM
Identity
- Trade Name
- RENOVA SPINE BALLOON CATHETER EUDAMED
- Device Name
- KYPHOPLASTY SYSTEMS EUDAMEDRENOVA SPINE BALLOON CATHETER EUDAMEDRENOVA SPINE BALLOON CATHETER [EN] EUDAMED
- Model / Reference
- RESB10VM EUDAMEDRESB20VM EUDAMEDRESB15VM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860017545 EUDAMED08033860017804 EUDAMED08033860017965 EUDAMED
- Basic UDI-DI
- 8033860KYPFT05A9T EUDAMEDB-08033860017965 EUDAMEDB-08033860017545 EUDAMEDB-08033860017804 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 Balloon Catheter by Biopsybell Srl — Class IIa — MDD, FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 8033860KYPFT05A9T | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K231340 | 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 (7)
- EUDAMED 266cac4d-ac10-4800-b75d-1b2eaef1410c 61 fields · synced Aug 2, 2026
- EUDAMED 33cfa997-8c37-4f0f-8490-42571d69c922 61 fields · synced May 19, 2026
- EUDAMED faab4a1a-32ff-4644-8976-549854676d36 61 fields · synced May 19, 2026
- EUDAMED 8b573f5a-2e4e-4b2c-93a7-bf068f7cb604 61 fields · synced Jun 18, 2026
- EUDAMED 1e08d15f-63f2-442d-8002-18bb1cfe6271 61 fields · synced Jul 11, 2026
- EUDAMED d5f7d499-d7ef-4463-b32c-0c5354ac6c30 61 fields · synced Aug 2, 2026
- FDA 510(k) K231340 1 fields · synced May 18, 2026