Identity
- Trade Name
- VERTEBRAL BIOPSY NEEDLE EUDAMEDKYPHOKIT VERTEBRAL BIOPSY NEEDLE EUDAMED
- Device Name
- NEEDLES FOR BIOPSY OR EXPLANT EUDAMED
- Model / Reference
- MED-FU11 EUDAMEDKK11-FU1517 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860044640 EUDAMED08033860044725 EUDAMED
- Basic UDI-DI
- 8033860BIOEFT01U5 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
Vertebral Biopsy Needle 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 | 8033860BIOEFT01U5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (2)
- EUDAMED d73e9f89-3194-45d7-b0e7-b1f169c65c32 61 fields · synced Jul 12, 2026
- EUDAMED 4c299e08-1348-47ae-87cd-1092f2b9fa46 61 fields · synced May 18, 2026