WSAUD WIDEX HEARING AIDS (BTE, DIGITAL, WIRELESS) - HSA Registration DE0506566
Access comprehensive regulatory information for WSAUD WIDEX HEARING AIDS (BTE, DIGITAL, WIRELESS) in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506566 and owned by WSAUD A/S. The device was registered on January 07, 2022.
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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HSA Official Data
CLASS B
DE0506566
WSAUD WIDEX HEARING AIDS (BTE, DIGITAL, WIRELESS)
HSA Registration Number: DE0506566
Product Description
The hearing aids are indicated for individuals with a range of hearing loss from minimal (10 dB HL) to severe-to-profound (105 dB HL) and all hearing loss configurations. They are to be programmed by licensed hearing care professionals (audiologists, hearing aid specialists, otolaryngologists) who are trained in hearing (re)habilitation. For Moment (MBR3D) hearing aid, it is only indicated for individuals older than 36 months.
Device Classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
Registration Information
Registration Number
DE0506566
Registration Date
January 07, 2022
Retention Due Date
January 06, 2026
Product Owner
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)
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MOMENT MBR3D
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MOMENT MBR3D 440
MOMENT MBR3D 440
MOMENT MBR3D 440 DEMO
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MOMENT MBR3D
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MOMENT MBR3D 220
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MOMENT MBR3D 440
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MOMENT MBR3D 440
MOMENT MBR3D 440
MOMENT MBR3D 440 DEMO
WIDEX COMPASS GPS
WIDEX MOMENT APP
Model Identifier(s)
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8 412 0103 136
8 412 0171 068
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8 412 0220 068
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8 412 0220 136
8 412 0230 068
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8 412 0230 114
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8 412 0230 116
8 412 0230 118
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8 412 0230 123
8 412 0230 136
8 412 0240 068
8 412 0240 076
8 412 0240 077
8 412 0240 078
8 412 0240 114
8 412 0240 115
8 412 0240 116
8 412 0240 118
8 412 0240 119
8 412 0240 120
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8 412 0240 136
8 412 0242 119
WIDEX COMPASS GPS
WIDEX MOMENT APP