Owlet has secured the UK Conformity Assessed (UKCA) certification from a recognised UK-approved body for its Dream Sock device for monitoring infants’ vital signs.
The certification complements the recent CE Mark certification for the medical-grade infant monitoring technology, allowing Owlet to reach parents and caregivers in key UK and European markets.
Dream Sock is designed to monitor healthy infants’ oxygen saturation and pulse rate, providing caregivers with vital sleep insights.
With the latest certification, Owlet can now distribute the Dream Sock device in the UK.
The UKCA certification also comes on the heels of Owlet’s acquisition of marketing authorisations from the US Food and Drug Administration (FDA) for the Dream Sock over-the-counter device.
The FDA authorisation was granted for Owlet’s Dream Sock device and BabySat, which is intended for infants with acute or chronic medical conditions.
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By GlobalData
Owlet’s Dream Sock wraps around an infant’s foot, providing parents with real-time data on their child’s well-being.
Suitable for infants aged 0-18 months, weighing between 2.5kg and 13.6kg, the device is intended for routine surveillance of healthy infants at home, offering a new level of sleep insight to the UK market.
The Dream Sock’s technology is clinically proven for accuracy, and the accompanying Owlet Dream App delivers live readings to mobile devices.
Additionally, a Base Station can notify caregivers, prompting them to check on the infant.
Owlet is planning to launch the Dream Sock device at major UK, German, and French retailers shortly. It also plans to expand the launch to other European countries later in the year.
Owlet president and chief revenue officer Jonathan Harris said: “With the addition of the UKCA certification, Owlet is now able to increase its reach throughout the European market, where more than 3.8 million babies are born each year.
“Owlet is extremely well-positioned to take advantage of both the UKCA and EU medical certifications with key retail partnerships across the European market.
“These partnerships will allow the company to reach a wider range of consumers and make its products more accessible to families in the region.”
