Identity
- Trade Name
- KYPHOSET VERTEBRAL BIOPSY NEEDLE EUDAMED
- Device Name
- KYPHOSET VERTEBRAL BIOPSY NEEDLE EUDAMEDNEEDLES FOR BIOPSY OR EXPLANT EUDAMED
- Model / Reference
- 11KSBIO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860036386 EUDAMED
- Basic UDI-DI
- B-08033860036386 EUDAMED8033860BIOEFT01U5 EUDAMED
- EMDN Code
- A01020203 VERTEBRAL AND PARAVERTEBRAL BIOPSY NEEDLES AND KITS 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 Vertebral Biopsy Needle 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 | B-08033860036386 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | B-08033860036386 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (2)
- EUDAMED b5aa1e74-a774-4b34-bef0-f6e392f8b220 61 fields · synced Jun 19, 2026
- EUDAMED 84f0ae26-786b-4d62-aec3-b68f6164ee50 61 fields · synced May 17, 2026