Identity
- Trade Name
- Spinertome EUDAMED
- Device Name
- Devices for percutaneous discectomy and motorized for vertebroplasty / kyphoplasty EUDAMED
- Model / Reference
- 5051307 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053175000865 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
Category: Intraosseous infusion kit
Spinertome by Adria S.r.l. — Class IIb — 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/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 c677ab36-87fb-4d8f-8129-16d63eba1f8a 61 fields · synced Jul 31, 2026