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Kyphokit Classic Access System
EUDAMEDClass IIa (EU MDR)
Ref KK08-002LRef KK08-001L-AMS
Identity
- Trade Name
- KYPHOKIT CLASSIC ACCESS SYSTEM EUDAMED
- Device Name
- KYPHOKIT CLASSIC ACCESS SYSTEM EUDAMEDKYPHOPLASTY SYSTEMS EUDAMED
- Model / Reference
- KK08-002L EUDAMEDKK08-001L-AMS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860035198 EUDAMED08033860027940 EUDAMED
- Basic UDI-DI
- B-08033860035198 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 Classic 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-08033860035198 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08033860035198 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (3)
- EUDAMED e31cce3c-a82c-45b8-9c6b-8e1c77b36d5b 61 fields · synced Aug 4, 2026
- EUDAMED 3a88649b-01ce-4880-a4bc-1098b2ace3c0 61 fields · synced May 18, 2026
- EUDAMED 5a97a7fe-7f73-4def-ad4e-37adde9dc2d3 61 fields · synced May 18, 2026