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Le Reve HealthCare Pty Ltd (AKA Caremax) Foetal Doppler system Model: JPD 100S mini, JPD 100S6+, JPD 100S9 (cancelled from Australian Register of Therapeutic Goods)

Product name
Foetal Doppler system [34040]: Model: JPD 100S mini, JPD 100S6+, JPD 100S9
ARTG
316781
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, the sponsor failed to comply with a condition to which inclusion of the kind of device in the ARTG was subject.

Device names
Foetal Doppler system
Model: JPD 100S mini, JPD 100S6+, JPD 100S9

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