Identity
- Trade Name
- KYPHOSET FAST ACCESS SYSTEM EUDAMED
- Device Name
- KYPHOSET FAST ACCESS SYSTEM EUDAMEDKYPHOPLASTY SYSTEMS EUDAMED
- Model / Reference
- 11KSD01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860038762 EUDAMED
- Basic UDI-DI
- B-08033860038762 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
Kyphoset Fast Access System by Biopsybell Srl — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08033860038762 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08033860038762 | 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 (2)
- EUDAMED d503a3bb-3f7c-4e93-a54b-89a87e528cd3 61 fields · synced Jul 24, 2026
- EUDAMED 8b4c5fd5-ee6e-4c46-a400-110ca4b198ce 61 fields · synced May 19, 2026