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Aditus Kyphoplasty Working Cannula And Bevel Tip
EUDAMEDClass IIa (EU MDR)
Ref AK11BRef AK13B
Identity
- Trade Name
- ADITUS KYPHOPLASTY WORKING CANNULA AND BEVEL TIP EUDAMED
- Device Name
- ADITUS KYPHOPLASTY WORKING CANNULA AND BEVEL TIP EUDAMEDKYPHOPLASTY SYSTEMS EUDAMED
- Model / Reference
- AK11B EUDAMEDAK13B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860033736 EUDAMED08033860034290 EUDAMED
- Basic UDI-DI
- B-08033860033736 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
Aditus Kyphoplasty Working Cannula And Bevel Tip 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-08033860033736 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08033860033736 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (3)
- EUDAMED 76cf7478-0e79-4a1b-b02e-dc5f206dda9f 61 fields · synced Jul 24, 2026
- EUDAMED ec694e94-14f1-4ad7-8c63-d9bf7062d3e2 61 fields · synced May 18, 2026
- EUDAMED 81aedbe3-eca0-466c-a1fe-e237e6f3a0d4 61 fields · synced May 19, 2026