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SaniteX Global Pty Ltd - Pulse oximeter, battery-powered (Cancellation from the ARTG under subsection 41GN(1) of the Act)
Product name
Pulse oximeter, battery-powered
Sponsor
ARTG details
- 382632
Date action takes effect
Compliance action
Medical device cancellation
Type of action
Cancellation from the ARTG under subsection 41GN(1) of the Act
Grounds for regulatory action
The sponsor did not provide sufficient information to substantiate compliance with the Essential Principles (see subparagraph 41FN(3)(a)(i) of the Act) or have procedures in place to ensure that such information can be obtained from the manufacturer of the Device within the period specified in 20 working days.