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Aditus Kyphoplasty Working Cannula And Diamond Tip
EUDAMEDClass IIa (EU MDR)
Ref AK13DIRef AK11DI
Identity
- Trade Name
- ADITUS KYPHOPLASTY WORKING CANNULA AND DIAMOND TIP EUDAMED
- Device Name
- KYPHOPLASTY SYSTEMS EUDAMED
- Model / Reference
- AK13DI EUDAMEDAK11DI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860034337 EUDAMED08033860033774 EUDAMED
- Basic UDI-DI
- 8033860KYPFT05A9T 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 Diamond Tip by Biopsybell Srl — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 bdb200d0-4f43-4069-943b-ba4408d2f445 61 fields · synced Jul 26, 2026
- EUDAMED ba1d6695-c7fd-4d56-bcc9-6beeac6a699d 61 fields · synced May 19, 2026