← Back to catalogue
Vertebroneedle
EUDAMEDClass IIa (EU MDR)
Ref VTKC1515EC-ABRef VTKC1518EC-ABRef KMVT1315201C-ARef KMVT1312200C-ARef KMVT1312400C-ARef KMVT1112002C-ARef KMVT1115000C-ARef VTKEB1520EC-ABRef KMVT1310201C-ARef KMVT1107025C-ARef KMVT1315001C-ARef KMVT1315200C-AF
Identity
- Trade Name
- VERTEBRONEEDLE EUDAMED
- Device Name
- VERTEBROPLASTY SYSTEMS EUDAMED
- Model / Reference
- VTKC1515EC-AB EUDAMEDVTKC1518EC-AB EUDAMEDKMVT1315201C-A EUDAMEDKMVT1312200C-A EUDAMEDKMVT1312400C-A EUDAMEDKMVT1112002C-A EUDAMEDKMVT1115000C-A EUDAMEDVTKEB1520EC-AB EUDAMEDKMVT1310201C-A EUDAMEDKMVT1107025C-A EUDAMEDKMVT1315001C-A EUDAMEDKMVT1315200C-AF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860000684 EUDAMED08033860012311 EUDAMED08033860002190 EUDAMED08033860002213 EUDAMED08033860006037 EUDAMED08033860018580 EUDAMED08033860007232 EUDAMED08033860012458 EUDAMED08033860001544 EUDAMED08033860014872 EUDAMED08033860000646 EUDAMED08033860002374 EUDAMED
- Basic UDI-DI
- 8033860VERTFT05CL EUDAMED
- EMDN Code
- A019011 INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION 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
Category: Intraosseous infusion kit
Vertebroneedle by Biopsybell Srl — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Intraosseous infusion kit.
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- ARROW — TELEFLEX INCORPORATED · Class I
- Spinertome kit — Adria S.r.l. · Class IIb
- Cook — COOK INCORPORATED · Class II
- SPASY — Seawon Meditech Co.,Ltd. · Class IIa
- X-Pander - Direct access kit — Adria S.r.l. · Class IIb
- SAM IO Intraosseous Access System — SAM Medical Products · Class II
- ShippertTech — ACTUATED MEDICAL, INC. · Class II
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 | 8033860VERTFT05CL | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (12)
- EUDAMED 0404c2a6-d304-4def-820b-d93a00e30a70 61 fields · synced Jul 26, 2026
- EUDAMED e7ea5efb-264b-46bf-ae1b-0f3796567c35 61 fields · synced May 17, 2026
- EUDAMED 09c51ffa-e790-4ca8-bcc3-011167f1b473 61 fields · synced May 17, 2026
- EUDAMED 6a03ff1c-ed27-45a4-9c0e-729a6deacf46 61 fields · synced May 17, 2026
- EUDAMED 910e2849-cd1a-4517-be35-ce4a2cdae40a 61 fields · synced May 17, 2026
- EUDAMED 987c9088-78bd-4de3-9f63-c1e3875a4327 61 fields · synced May 17, 2026
- EUDAMED 4b6f0723-453b-4296-97ea-b655ae26e0e8 61 fields · synced May 17, 2026
- EUDAMED da356934-d347-48bc-9d1b-cc70df2d089e 61 fields · synced May 18, 2026
- EUDAMED b98c8364-d52f-4c33-bd08-ab9084ccf3a7 61 fields · synced May 18, 2026
- EUDAMED 2e5ac5eb-f2da-4c84-afe6-4d2614debb10 61 fields · synced May 18, 2026
- EUDAMED 35f8aa04-29b0-4211-ab32-9da44a1e3345 61 fields · synced May 18, 2026
- EUDAMED 194b165b-272b-4f63-8a06-2f11179cec26 61 fields · synced May 19, 2026