WIDEX WIDEX MOMENT HEARING AIDS (BTE, DIGITAL, WIRELESS) - HSA Registration DE0504479
Access comprehensive regulatory information for WIDEX WIDEX MOMENT 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 DE0504479 and owned by Widex A/S. The device was registered on May 13, 2020.
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.
The hearing aids are intended as air conduction amplification devices to be used in everyday listening environments. The hearing aids may be equipped with the Zen program intended to provide a relaxing sound background (i.e. music/noise source) for adults who desire to listen to such a background in quiet. The MRB2D hearing aid models are indicated for individuals older than 36 months with a range of hearing loss from minimal (10 db HL) to severe-to-profound (100 dB HL) and all hearing loss configurations. The MRB0 hearing aid models are indicated for individuals older than 36 months with a range of hearing loss from slight (16 dB HL) to moderately severe (up to 85 dB HL) and all hearing loss configurations. The MRR2D hearing aid models are indicated for individuals older than 36 months with a range of hearing loss from minimal (0 dB HL) to severe-to-profound (115 dB HL) and all hearing loss configurations.

