Tyto Care’s Compliance department manages registrations and listings with the FDA, and all other regulatory authorities, in territories in which Tyto Care holds business. This encompasses adherence to the EU MDR as certified by the Notified Body, along with compliance with Health Canada, the Australian TGA, Japan’s RCB, Brazil’s ANVISA, Israeli’s AMAR and other regulatory authorities. Among the products that have received regulatory approvals are:
- The Tyto Stethoscope and Tyto Thermometer, which have both received clearance from the U.S. FDA. The Tyto Otoscope and Tyto Exam Camera are FDA listed devices in compliance with the FDA’s requirements.
- The Tyto Stethoscope, Tyto Thermometer, Tyto Otoscope and Tyto Exam Camera bear the CE marking demonstrating compliance with the EU MDR requirements.
- The Tyto Insights for Wheeze Detection has been cleared by the US FDA.
- The EU model of Tyto Insights for Wheeze Detection bears the CE marking in compliance with the EU MDD and MDR applicable requirements [the device is intended only for healthcare professionals].
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