Identity
- Trade Name
- KYPHOSET BONE FILLER EUDAMED
- Device Name
- KYPHOPLASTY SYSTEMS EUDAMEDKYPHOSET BONE FILLER EUDAMED
- Model / Reference
- 11KSFILLER1 EUDAMED08KSFILLER1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860035525 EUDAMED08033860046736 EUDAMED
- Basic UDI-DI
- 8033860KYPFT05A9T EUDAMEDB-08033860046736 EUDAMEDB-08033860035525 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
Kyphoset 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 (4)
- EUDAMED ce5fce8e-f988-4660-bbcc-9560a96c3402 61 fields · synced Aug 3, 2026
- EUDAMED ffc9c259-8c70-4bf5-b861-faa37e5696e9 61 fields · synced May 18, 2026
- EUDAMED 769d0e1a-28cf-4e2f-b3fe-226b3feeb19e 61 fields · synced Jul 26, 2026
- EUDAMED 0e488a8d-52c9-4d8c-a92c-3eba2c688947 61 fields · synced Aug 3, 2026