Identity
- Trade Name
- KYPHOKIT BONE FILLER EUDAMED
- Device Name
- KYPHOPLASTY SYSTEMS EUDAMEDKYPHOKIT BONE FILLER EUDAMED
- Model / Reference
- KK13-FIL EUDAMEDKK08-FIL3-AMS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860035419 EUDAMED08033860029449 EUDAMED
- Basic UDI-DI
- 8033860KYPFT05A9T EUDAMEDB-08033860035419 EUDAMEDB-08033860029449 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
Kyphokit Bone Filler by Biopsybell Srl — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Intraosseous infusion kit.
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- ARROW — TELEFLEX INCORPORATED · Class I
- Spinertome kit — Adria S.r.l. · Class IIb
- Cook — COOK INCORPORATED · Class II
- SPASY — Seawon Meditech Co.,Ltd. · Class IIa
- X-Pander - Direct access kit — Adria S.r.l. · Class IIb
- SAM IO Intraosseous Access System — SAM Medical Products · Class II
- ShippertTech — ACTUATED MEDICAL, INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (4)
- EUDAMED ddf050fd-f642-4c28-bb09-5c41ed5e3563 61 fields · synced Sep 18, 2026
- EUDAMED d56ed633-b276-4893-a2af-3658455a641a 61 fields · synced May 18, 2026
- EUDAMED a8817271-bc1f-4db7-b84d-4e1f03db6f88 61 fields · synced Jun 19, 2026
- EUDAMED 86b1550b-5c4f-4aa0-b7ea-90a47bf23c2e 61 fields · synced Jul 31, 2026