Identity
- Trade Name
- KYPHOKIT BONE FILLER EUDAMED
- Device Name
- KYPHOKIT BONE FILLER EUDAMEDKYPHOPLASTY SYSTEMS EUDAMED
- Model / Reference
- KK11-FIL3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860036706 EUDAMED
- Basic UDI-DI
- B-08033860036706 EUDAMED8033860KYPFT05A9T 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
Kyphokit Bone Filler by Biopsybell Srl — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08033860036706 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08033860036706 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (2)
- EUDAMED b99eec67-191d-403e-97da-b1ae3d4ec5ea 61 fields · synced Aug 1, 2026
- EUDAMED 04bcf4ba-46d4-4883-97ae-150db0c117c5 61 fields · synced May 19, 2026