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Is Snuza a medical device?

device medical snuza
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Is Snuza a medical device?

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No, strictly speaking by definition of MDD 93/42/EEC and 2007/47/EEC, Snuza is not a medical device. It falls into a similar class of device as exercise heart-rate monitors (the kind that has a strap around your chest and transmits your heart rate to a watch); all this device is used for is to monitor breathing movement. It should not be used to diagnose, monitor, treat or alleviate a disease, injury or handicap. Nor should it be used to investigate (i.e. find the cause of) a physiological process (i.e. breathing).

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