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Samsung Electronics’ Galaxy Watch series has received the European Union’s Conformite Europeenne (CE) certification for its sleep apnea detection feature, expanding its availability worldwide.

The company announced Friday that the feature recently gained certification for the European Economic Area of 34 markets. Along with Korea, the United States, Australia and Singapore, the feature is now available in 70 markets.

The CE certification, which translates to European conformity, confirms a product meets the European Union’s safety, health, environmental and consumer protection requirements. The CE marking is obligatory for products like medical devices, electronics, machinery and toys to be marketed in the EU.

Sleep apnea is a condition in which breathing repeatedly stops and starts during sleep, potentially leading to serious health complications. When breathing temporarily stops, it reduces oxygen levels in the blood, disrupting sleep quality and resulting in daytime fatigue.

According to the U.S. National Sleep Foundation, around 25 percent of men and 10 percent of women in the United States suffer from obstructive sleep apnea. However, many of them are not aware they have the condition, which only worsens it as they do not seek medical treatment.

Samsung’s sleep apnea detection feature is an over-the-counter mobile medical app that runs on Galaxy Watch devices and their connected smartphones.

Using Galaxy Watch’s BioActive sensor, the feature tracks blood oxygen levels while a user sleeps and analyzes patterns that may indicate apnea or hypopnea (shallow or slow breathing) episodes, which then estimates an apnea-hypopnea index to determine whether the user shows signs of the condition.

This CE designation is the latest milestone in a string of global regulatory approvals for the feature. In 2023, it obtained a Software as a Medical Device approval from Korea’s Ministry of Food and Drug Safety, and received De Novo authorization from the U.S. Food and Drug Administration last year, marking the first of its kind for a wearable device.

“This expanded access will help more users detect symptoms early and take action toward better sleep health,” Samsung said in a press release. “We will continue supporting users in managing their health and developing healthy sleep habits through Galaxy Watch.”