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Renova Spine Bone Filler
EUDAMEDClass IIa (EU MDR)
Ref RESFIL1112C1CH3Ref RESFIL1312C3Ref RESFIL1512C3Ref RESFIL1212C3Ref RESFIL1112C1CH-EM
Identity
- Trade Name
- RENOVA SPINE BONE FILLER EUDAMED
- Device Name
- KYPHOPLASTY SYSTEMS EUDAMEDRENOVA SPINE BONE FILLER EUDAMED
- Model / Reference
- RESFIL1112C1CH3 EUDAMEDRESFIL1312C3 EUDAMEDRESFIL1512C3 EUDAMEDRESFIL1212C3 EUDAMEDRESFIL1112C1CH-EM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860020385 EUDAMED08033860022167 EUDAMED08033860022181 EUDAMED08033860019266 EUDAMED08033860025830 EUDAMED
- Basic UDI-DI
- 8033860KYPFT05A9T EUDAMEDB-08033860019266 EUDAMEDB-08033860025830 EUDAMEDB-08033860022167 EUDAMEDB-08033860020385 EUDAMEDB-08033860022181 EUDAMED
- EMDN Code
- A019011 INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS 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
Category: Intraosseous infusion kit
Renova Spine Bone Filler by Biopsybell Srl — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 (10)
- EUDAMED 1f912403-a17e-43cf-a13a-94f3d52ed08f 61 fields · synced Jul 22, 2026
- EUDAMED 28084c61-c6c8-4386-9d84-41295b8c10f4 61 fields · synced May 16, 2026
- EUDAMED 02f3029c-34db-48ef-aecd-d36090f458c0 61 fields · synced May 17, 2026
- EUDAMED a80d4287-a328-42a9-a5dd-671a22a09329 61 fields · synced May 17, 2026
- EUDAMED 0dd372b8-2931-4ef2-9453-185edb97b7d9 61 fields · synced May 18, 2026
- EUDAMED fdbad34f-2878-44ef-a643-9d87ccbe5ff7 61 fields · synced Jul 9, 2026
- EUDAMED bbcea3c0-5e6a-48e3-a40e-61c9734a7489 61 fields · synced Jul 9, 2026
- EUDAMED efc27456-e715-44d1-944c-bdb207e8d690 61 fields · synced Jul 17, 2026
- EUDAMED d8828f3c-08bc-4cfe-8196-0e7f7dc6c2da 61 fields · synced Jul 19, 2026
- EUDAMED 08289378-9a14-4ee7-9f6b-73224ff51ba0 61 fields · synced Jul 22, 2026