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Nuheara: Achieves international medical device quality certification | Fintech InShorts: Latest fintech news, analysis by experts
Monday, December 23, 2024

Nuheara: Achieves international medical device quality certification

Nuheara Achieves international medical device quality certification

  • Nuheara (NUH) has achieved international medical device quality certification in addition to the certification for its non-regulated devices
  • The company received 13485:2016 certification which means Nu heara has successfully met all the requirements, mainly whether it is effective while safe to use
  • The company says this certification is an “important next milestone” after receiving FDA approval for its HP Hearing PRO over the counter (OTC) self-fit hearing aid
  • Managing Director Justin Miller says the certification is another key step in rolling out company’s medical device growth strategy in the US
  • Shares in the company are down 2 per cent to trade at 24.5 cents at 1:53 pm AEDT

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