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Singapore HSA registration DE0017453

Widex Widex Hearing Aids (CIC)

Singapore flagSingapore·CLASS B·Widex A/S·Registered August 31, 2015
Device classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
HSA Product Code
HSAMDB00111
HS Code
90214000
Registration information
Registration Number
DE0017453
Registration Date
August 31, 2015
Change Notification Approval Date
June 28, 2022
Retention Due Date
August 30, 2025
Product description
A device used to help provide hearing sensation to a hearing impaired person by transmitting amplified sounds to the eardrum.
Product Owner
Name
Widex A/S
Short Name
Widex A/S
Address
Nymoellevej 6, 3540 Lynge, Denmark, DENMARK
Registrant
Name
WIDEX SINGAPORE PTE. LTD.
Address
2 SHENTON WAY, SGX CENTRE I, #18-01, SINGAPORE 068804
Importer
Name
SIVANTOS PTE. LTD. WIDEX SINGAPORE PTE. LTD. WS Audiology SEA Pte Ltd
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)
COMPASS GPS version 3.0 Widex EVOKE E-CIC-M Widex EVOKE E-CIC-M Widex EVOKE E-CIC-M Widex EVOKE E-CIC-M TR Widex EVOKE E-CIC-M TR Widex EVOKE E-CIC-M TR Widex Unique U-CIC-M Widex Unique U-CIC-M Widex Unique U-CIC-M Widex Unique U-CIC-M (TR) Widex Unique U-CIC-M (TR) Widex Unique U-CIC-M (TR) Widex Dream D-CIC-M Widex Dream D-CIC-M Widex Dream D-CIC-M Widex Dream D-CIC-M (TR) Widex Dream D-CIC-M (TR) Widex Dream D-CIC-M (TR) COMPASS GPS version 3.0 COMPASS GPS version 3.0 SP1 COMPASS GPS version 3.0 SP1 COMPASS GPS version 2.0
Model Identifier(s)
7 503 0127 8 406 0500 025 8 406 0500 028 8 406 0500 107 8 406 0600 025 8 406 0600 028 8 406 0600 107 83160500025 83160500027 83160500028 83160600025 83160600027 83160600028 83460500025 83460500027 83460500028 83460600025 83460600027 83460600028 9 503 0888 9 503 0899 9 512 0089 Compass GPS 2.0
About this record

Access comprehensive regulatory information for Widex Widex Hearing Aids (CIC) in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0017453 and owned by Widex A/S. The device was registered on August 31, 2015.

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.

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