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Stiletto Spingitore
EUDAMEDClass IIa (EU MDR)
Ref IVTELL1315Ref IVTELL1510Ref KVE1512Ref IVTELL1112Ref IVTELL1512Ref KVE1110Ref IVTELL1115Ref IVTELL1310Ref KVE1113Ref IVTELL1515
Identity
- Trade Name
- STILETTO SPINGITORE EUDAMED
- Device Name
- VERTEBROPLASTY SYSTEMS EUDAMEDSTILETTO SPINGITORE EUDAMED
- Model / Reference
- IVTELL1315 EUDAMEDIVTELL1510 EUDAMEDKVE1512 EUDAMEDIVTELL1112 EUDAMEDIVTELL1512 EUDAMEDKVE1110 EUDAMEDIVTELL1115 EUDAMEDIVTELL1310 EUDAMEDKVE1113 EUDAMEDIVTELL1515 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860024444 EUDAMED08033860024499 EUDAMED08033860025335 EUDAMED08033860025670 EUDAMED08033860024468 EUDAMED08033860025311 EUDAMED08033860024482 EUDAMED08033860024437 EUDAMED08033860025342 EUDAMED08033860026103 EUDAMED
- Basic UDI-DI
- 8033860VERTFT05CL EUDAMEDB-08033860024499 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
Stiletto Spingitore by Biopsybell Srl — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 8033860VERTFT05CL | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8033860VERTFT05CL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (11)
- EUDAMED 9f49e041-8881-41e2-8a39-860c5848c4cc 61 fields · synced Aug 1, 2026
- EUDAMED 9c25c44e-8bfc-42fc-b529-687232b5900d 61 fields · synced May 16, 2026
- EUDAMED 8c380f47-a5d4-48bc-ae41-5cc957fff9ed 61 fields · synced May 16, 2026
- EUDAMED c51de8bf-9645-4975-863f-3f4380f9f65c 61 fields · synced May 17, 2026
- EUDAMED 517435a4-5133-4127-b12e-d3ac80de8c14 61 fields · synced May 17, 2026
- EUDAMED 8b0056d1-aa71-4183-b2e6-e7916e494d14 61 fields · synced May 17, 2026
- EUDAMED f7cd2d9e-c6ab-49ff-a959-793fa1f9b709 61 fields · synced May 17, 2026
- EUDAMED 01d673dd-07e1-4090-9219-61d161fbdc89 61 fields · synced May 18, 2026
- EUDAMED 6ba4e68e-af95-453b-8c21-45fdd844857d 61 fields · synced May 18, 2026
- EUDAMED 7054afeb-8f63-461c-8c4d-a128d4ae87d0 61 fields · synced May 18, 2026
- EUDAMED 6926f623-bd24-4bb9-b1c7-66ea326d6c50 61 fields · synced Jul 30, 2026