Identity
- Trade Name
- SANZA BILATERAL FAST ACCESS KIT EUDAMED
- Device Name
- KYPHOPLASTY SYSTEMS EUDAMEDSANZA BILATERAL FAST ACCESS KIT EUDAMED
- Model / Reference
- FAK-11G-B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860035815 EUDAMED
- Basic UDI-DI
- 8033860KYPFT05A9T EUDAMEDB-08033860035815 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 Bilateral Fast Access Kit 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 30f5cd6c-a9ca-4acd-acd9-fd41cb642fbc 61 fields · synced Jul 23, 2026
- EUDAMED c9c30e4b-5419-4d09-a06e-b114341d36d5 61 fields · synced May 18, 2026