Pure Global

Widex Widex Zen – Tinnitus Management App - HSA Registration DE0501332

Access comprehensive regulatory information for Widex Widex Zen – Tinnitus Management App in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0501332 and owned by Widex A/S. The device was registered on March 06, 2018.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS B
DE0501332
Widex Widex Zen – Tinnitus Management App
HSA Registration Number: DE0501332
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The Zen sounds presented in the playlist are intended to be used in quiet where hearing everyday sounds is not critical. The sounds are intended to provide a relaxing sound background for those who desire to listen to such a background in quiet. The Zen sounds are intended for people with tinnitus and a Widex hearing aid. The counseling tool which consists of “Sleep” ,”Relaxation” and “Learn”, is intended to increase patient awareness about how to live with their tinnitus, through education The Zen sounds may be used as sound therapy tool in a tinnitus treatment program that is prescribed by a licenced hearing healthcare professional (audiologist, hearing care specialists, otolaryngologists) who is trained in tinnitus

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
Registration Information
Registration Number
DE0501332
Registration Date
March 06, 2018
Retention Due Date
March 05, 2026
Product Owner
Short Name
Widex A/S
Address
Nymoellevej 6, 3540 Lynge, Denmark, DENMARK
Registrant
Address
2 SHENTON WAY, SGX CENTRE I, #18-01, SINGAPORE 068804
Importer
Address
18 TAI SENG STREET, 18 TAI SENG, #08-08, SINGAPORE 539775 2 SHENTON WAY, SGX CENTRE I, #18-01, SINGAPORE 068804 18 TAI SENG STREET, 18 TAI SENG, #08-08, SINGAPORE 539775
Model Information
Model Name(s)
Widex Widex Zen – Tinnitus Management App (Android Version) Widex Widex Zen – Tinnitus Management App (iOS) version)
Model Identifier(s)
Widex Zen – Tinnitus Management App (Android version) Widex Zen – Tinnitus Management App (iOS version)