Identity
- Trade Name
- KYPHOKIT BALLOON CATHETER EUDAMED
- Device Name
- KYPHOKIT BALLOON CATHETER EUDAMEDKYPHOPLASTY SYSTEMS EUDAMED
- Model / Reference
- KBAL10J EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860034641 EUDAMED
- Basic UDI-DI
- B-08033860034641 EUDAMED8033860KYPFT05A9T 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 | B-08033860034641 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | B-08033860034641 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (2)
- EUDAMED e5f8ac94-f57d-4698-b768-6ca8193954a7 61 fields · synced Jun 18, 2026
- EUDAMED 29a40cad-aa3d-4b1c-bb16-d636d8e8701a 61 fields · synced May 16, 2026