Identity
- Trade Name
- Needle fiducial - Sensor IR EUDAMED
- Device Name
- Needle fiducial - Sensor IR EUDAMED
- Model / Reference
- SIR000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08052141890110 EUDAMED
- Basic UDI-DI
- 8052141890004SIR0JG EUDAMED
- Direct Marketing DI
- 08052141890110 EUDAMED
- EMDN Code
- Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES 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: Neurological stereotactic surgery system
Needle fiducial - Sensor IR by R.A.W. Srl — Class IIa — 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 | 8052141890004SIR0JG | Class IIa | Active |
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Manufacturer
- Manufacturer
- R.A.W. Srl
- EUDAMED SRN
- IT-MF-000027589
Sources (1)
- EUDAMED 2e5b119b-983a-4921-8186-c0543bd2dbbb 61 fields · synced Jul 31, 2026