Outset Medical

7 devices 10 registrations
✕ UK (MHRA) ✕ EU (EUDAMED) ✕ AU (TGA)
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Devices

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Device Name US UK CA AU EU
Tablo Cartridge Registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) Not registered with AU (TGA) Not registered with EU (EUDAMED)
Tablo Console Registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) Not registered with AU (TGA) Not registered with EU (EUDAMED)
Tablo Console with Wireless Capability 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)
Tablo Hemodialysis System Registered with US (FDA) Not registered with UK (MHRA) Registered with Canada (Health Canada) Not registered with AU (TGA) Not registered with EU (EUDAMED)
Tablo Hemodialysis System (PN-0008000, PN-0006000U) 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)
Tablo Hemodialysis System, Tablo Cartridge 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)
Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer 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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