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SightPilot NAVi Controller SNi-1 for REFRACTION SYSTEM Chronos
EUDAMEDClass I (EU MDR)
Ref SNi-1
Identity
- Trade Name
- SightPilot NAVi Controller SNi-1 for REFRACTION SYSTEM Chronos EUDAMED
- Device Name
- Optional Accessories for REFRACTION SYSTEM Chronos EUDAMED
- Model / Reference
- SNi-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04560126268655 EUDAMED
- Basic UDI-DI
- 4560126260061UB EUDAMED
- EMDN Code
- Z12120115 OPTOMETERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
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
SightPilot NAVi Controller SNi-1 for REFRACTION SYSTEM Chronos by Topcon Corporation — Class I — 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 | 4560126260061UB | Class I | Active |
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Manufacturer
- Manufacturer
- Topcon Corporation
- EUDAMED SRN
- JP-MF-000003928
- Authorised Representative
- Topcon Europe Medical BV NL-AR-000000441
Sources (1)
- EUDAMED 5e6a6638-1048-44c3-af01-24a27d3be6da 61 fields · synced Jul 9, 2026