DIRECT OUTPATIENT OTOSCOPES

Primary DI

05065005841022

Basic UDI-DI Code

5065005841ICS2W

Reference

5065005841022

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 1

Status

On The Market

The iCLEARscope kit consists of a CLEARscope otoscope and a CLEARlite portable light source. The CLEARlite is connected to the CLEARscope, and the CLEARscope is then connected to an iPhone SE 3rd Generation using the endoscope-i iPhone SE 3rd Generation adaptor. The iCLEARscope kit is inserted into the ear canal, and an image is generated using the onboard camera and the e-i Pro app. The app makes adjustments to the image possible and also acts as an image storage device. The clinical operative uses this image to see inside the ear from a distance and carry out a procedure to remove or manipulate wax. The iCLEARscope kit is indicated for use in patients with known or suspected ear wax impaction, blockage of the ear canal or abnormalities of the outer ear and eardrum.

The intended purpose of the earwax visualisation device kits is to view the inside of the ear to aid in ear wax removal procedures.

Other on-the-market devices with the same classification (Eu Md Class 1) and regulation (EU MDR).