Identity
- Trade Name
- SANZA BALLOON CATHETER EUDAMED
- Device Name
- KYPHOPLASTY SYSTEMS EUDAMEDSANZA BALLOON CATHETER EUDAMED
- Model / Reference
- BAL-015 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860035754 EUDAMED
- Basic UDI-DI
- 8033860KYPFT05A9T EUDAMEDB-08033860035754 EUDAMED
- EMDN Code
- K010301 SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON EUDAMEDA019011 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
Sanza 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 |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (2)
- EUDAMED fa50c96f-a0b6-48bf-829f-a1704c531de9 61 fields · synced Jul 18, 2026
- EUDAMED 340a627f-d844-4f6d-83e6-eedb1192747e 61 fields · synced May 19, 2026