Identity
- Trade Name
- KYPHOKIT BALLOON CATHETER EUDAMED
- Device Name
- KYPHOPLASTY SYSTEMS EUDAMEDKYPHOKIT BALLOON CATHETER EUDAMED
- Model / Reference
- KBAL20MC EUDAMEDKBAL15MC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860040284 EUDAMED08033860035471 EUDAMED
- Basic UDI-DI
- 8033860KYPFT05A9T EUDAMEDB-08033860035471 EUDAMEDB-08033860040284 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
Kyphokit Balloon Catheter by Biopsybell Srl — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
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 0384eea4-bf41-421e-bd50-5eb8847d76fc 61 fields · synced Sep 18, 2026
- EUDAMED 1e4a3806-83b9-4858-a9cf-3d463decbe8f 61 fields · synced May 18, 2026
- EUDAMED 3dbc3b17-89c8-4234-8114-d1a9e1d2ce75 61 fields · synced Jun 19, 2026
- EUDAMED dc11568f-570a-456b-98a9-84d060f30753 61 fields · synced Sep 18, 2026