Identity
- Trade Name
- Spinertome kit EUDAMED
- Device Name
- Devices for percutaneous discectomy and motorized for vertebroplasty / kyphoplasty EUDAMED
- Model / Reference
- 5061507 C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053175001312 EUDAMED
- Basic UDI-DI
- 803373711K0299VX EUDAMED
- EMDN Code
- A019011 INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS EUDAMED
Classification
- Device Class
- Class IIb 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
Spinertome kit by Adria S.r.l. — Class IIb — 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 | 803373711K0299VX | Class IIb | Active |
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Manufacturer
- Manufacturer
- Adria S.r.l.
- EUDAMED SRN
- IT-MF-000027852
Sources (1)
- EUDAMED 3ac32a2b-4abc-45e0-926a-b47907a04cba 61 fields · synced Jul 30, 2026