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Singapore HSA registration DE0507536

Sonova Unitron Insera hearing aids (Digital, Wireless, ITE)

Singapore flagSingapore·CLASS B·Sovona AG·Registered November 24, 2022
Device classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
Registration information
Registration Number
DE0507536
Registration Date
November 24, 2022
Retention Due Date
November 23, 2025
Product description
The intended use of the hearing is to amplify and transmit sound to the ears and thereby compensate for impaired hearing. The Tinnitus feature is intended for use by people with tinnitus who also desire amplification. It provides supplementary noise stimulation which can help defocus the user's attention from their tinnitus.
Product Owner
Name
Sovona AG
Short Name
Sovona AG
Address
Laubisrutistrasse 28, 8712 Stafa, SWITZERLAND
Registrant
Name
SONOVA SINGAPORE PTE. LTD.
Address
8 KALLANG AVENUE, APERIA, #13-08, SINGAPORE 339509
Importer
Name
SONOVA SINGAPORE PTE. LTD.
Address
21 MEDIA CIRCLE, INFINITE STUDIOS, #07-01/04, SINGAPORE 138562
Model information
Model Name(s)
Unitron TrueFit Unitron Insera B1-312 Unitron Insera B3-312 Unitron Insera B5-312 Unitron Insera B7-312 Unitron Insera B9-312 Unitron Remote Plus
Model Identifier(s)
058-5178 063-6303-01 063-6306-01 063-6309-01 063-6312-01 063-6315-01 088-5013
About this record

Access comprehensive regulatory information for Sonova Unitron Insera hearing aids (Digital, Wireless, ITE) in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507536 and owned by Sovona AG. The device was registered on November 24, 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B