orangedental GmbH & Co. KG

8 devices* 9 registrations
✕ UK (MHRA) ✕ Canada (Health Canada)
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Devices

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Device Name US UK CA AU EU
byzz nxt 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)
opt-on 2.7 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)
opt-on 3.3 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)
pa-on Einmalspitzen sterilisierbar 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)
pa-on parometer 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)
spot-on cordfree 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)
spot-on nxt 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)
SUNIRAY 5.2 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)

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