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Public respirator, single-use (M House Pty Ltd)

Product name
Public respirator, single-use
Baoji Taidakang Medical Technology Co Ltd
Scope of 9D variation
Variation of GMDN code and intended purpose to remove the 'N95' reference
Details of consent

Update 29 September 2020: The sponsor has provided new information to the TGA that demonstrates compliance with all regulatory requirements including the use of the 'N95' label to the device. Any supply of the stock of these devices has therefore been lawful.

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