OTOSPRAY

Primary DI

07350057840887

Basic UDI-DI Code

735005784001400DR

Reference

001402, 001401

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 1

Status

On The Market

Manufacturer

Bioglan AB

OTOSPRAY is an ear spray intended for facilitate cleaning of the external auditory canal by removing excess earwax and to prevent the formation of earwax plugs. The product is intended by the manufacturer to be used by adults and children from the age of 6 years old. When it is necessary to use it in children from 2 years of age or adults requiring a gentle spray, the use of OTOSPRAY Junior is recommended, due to the incorporation of a diffuser valve which provides a gentler spray. The spray can be used for self-administered treatment and is intended for transient use.

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