Ecential Robotics

6 devices 7 registrations
✕ UK (MHRA) ✕ Canada (Health Canada) ✕ AU (TGA)
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Devices

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Device Name US UK CA AU EU
3D OFFSET IMAGING SET SPX1 Not registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) Not registered with AU (TGA) Registered with EU (EUDAMED)
Navigation Set SPX1, Targeting Needle Bevel Tip – 11G, 125mm Not registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) Not registered with AU (TGA) Registered with EU (EUDAMED)
Op.n™ Spine Navigation and Robotic Guidance 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)
Op.n(TM) Navigation 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)
Spine Navigation and Robotic-Assistance Device 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)
SURGIVISIO Device Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) Not registered with AU (TGA) Registered with EU (EUDAMED)
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