MEDICAL REGULATORY CLEARANCE

MEDICAL REGULATORY CLEARANCE

The WAXscope and CLEARscope otoscope and endoscopes, as well as all other medical devices manufactured by Clearwax, are Class I medical devices and registered with the MHRA as well as Eudamed for use in the UK & Europe and as such bear a CE mark.

The UK & EU declaration of conformity state that the requirements specified in MDR Regulation (EU) 2017/745, and other applicable Union legislation as listed in Annex 1 to this declaration, have been fulfilled in relation to the devices listed in Annex 3 to this declaration.

It is important that any medical otoscope or endoscopes being used with the Clearwax App in any part of the world have similar medical regulatory clearance for use.

Euromed Registration of the Clearwax WAXscope & CLEARscope
EU Declaration of Conformity for Clearwax Earwax Visualisation Devices including the WAXscope & CLEARscope
MHRA Registration of the CLEARscope
MHRA Registration of the WAXscope