DIRECT OUTPATIENT OTOSCOPES

Primary DI

05065005841053

Basic UDI-DI Code

5065005841WSK64

Reference

5065005841053

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 1

Status

On The Market

The WAXscope kit consists of a WAXscope otoscope and a CLEARlite portable light source. The CLEARlite is connected to the WAXscope, and the WAXscope is then connected to an iPhone SE 3rd Generation using the endoscope-i iPhone SE 3rd Generation adaptor. A single-use and disposable specula is then attached to the WAXscope kit. The WAXscope 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 WAXscope 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).