Identity
- Trade Name
- KYPHOKIT DRILL EUDAMED
- Device Name
- KYPHOPLASTY SYSTEMS EUDAMEDKYPHOKIT DRILL EUDAMED
- Model / Reference
- KK11-DRI-AMS EUDAMEDKK13-DRI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860027933 EUDAMED08033860035402 EUDAMED
- Basic UDI-DI
- 8033860KYPFT05A9T EUDAMEDB-08033860035402 EUDAMEDB-08033860027933 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 Drill 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 (4)
- EUDAMED 901d58fd-b31e-417f-af50-26e3578b38da 61 fields · synced Jul 29, 2026
- EUDAMED f56558e8-dbb3-4ceb-8068-6145897407b9 61 fields · synced May 18, 2026
- EUDAMED 1689494c-2a4e-447a-8847-f4ed83436505 61 fields · synced Jul 14, 2026
- EUDAMED b98ce6a7-5768-4d22-a657-2d9766eed65b 61 fields · synced Jul 29, 2026