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References
Compliance Statement
Clarius products comply with international and national standards
and laws. Users are responsible for ensuring that the chosen smart
device and scanner are compliant with the law in the jurisdiction
where the product is used. Clarius meets all regulatory standards
listed in this chapter.
The Clarius Ultrasound Scanner
Product Classification
Classification:
• Device with scanners (internally powered ME equipment):
• Health Canada: Class III
• US FDA: Class II
• EU: Class IIa
• Scanners: Type BF applied parts, IP67
• Charger HD3: IP00
• Ordinary Equipment/Continuous Operation
• Non-AP/APG
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