BIONIT LABS SRL

Via Cracovia 1, Soleto, Italy, 73010

13 devices* 25 registrations
✕ Canada (Health Canada)
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Devices

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Device Name US UK CA AU EU
Adam's Hand Not registered with US (FDA) Registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Registered with EU (EUDAMED)
Adam's Skin Not registered with US (FDA) Registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Registered with EU (EUDAMED)
Analog Amplifier Not registered with US (FDA) Registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Registered with EU (EUDAMED)
Anlog Amplifier Not registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Registered with EU (EUDAMED)
MyoLogic Not registered with US (FDA) Registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Registered with EU (EUDAMED)
MyoLogic Pro Not registered with US (FDA) Registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Registered with EU (EUDAMED)
Myo Unit Not registered with US (FDA) Registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Registered with EU (EUDAMED)
Remote Wave Electrode Not registered with US (FDA) Registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Registered with EU (EUDAMED)
Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
ThunderCell Battery Not registered with US (FDA) Registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Registered with EU (EUDAMED)
Wave Electrode Not registered with US (FDA) Registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Registered with EU (EUDAMED)
Wave Electrode (AE02-60); Wave Electrode (AE02-50) Registered with US (FDA) Not registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Not registered with EU (EUDAMED)
Wrist Seal Not registered with US (FDA) Registered with UK (MHRA) Not registered with Canada (Health Canada) AU (TGA): manufacturer registered, device not confirmed Registered with EU (EUDAMED)

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