Edwards Lifeciences, LLC

3 devices 3 registrations
✕ UK (MHRA) ✕ EU (EUDAMED) ✕ Canada (Health Canada) ✕ AU (TGA)
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Devices

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Device Name US UK CA AU EU
Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) Not registered with AU (TGA) Not registered with EU (EUDAMED)
HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) Not registered with AU (TGA) Not registered with EU (EUDAMED)
TruWave Disposable Pressure Transducer Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) Not registered with AU (TGA) Not registered with EU (EUDAMED)

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