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Starkey Audibel Hearing Aids (BTE, Wireless, Digital) - HSA Registration DE0506130

Access comprehensive regulatory information for Starkey Audibel Hearing Aids (BTE, Wireless, Digital) in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506130 and owned by Starkey Laboratories, Inc. The device was registered on September 01, 2021.

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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CLASS B
DE0506130
Starkey Audibel Hearing Aids (BTE, Wireless, Digital)
HSA Registration Number: DE0506130
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Product Description

An air conduction hearing aid is a wearable sound-amplifying device that is intended to compensate for impaired hearing. Hearing aids are available in multiple gain/output levels appropriate to treat hearing losses ranging from mild to profound. The Multiflex Tinnitus Technology is a tool to generate sounds to be used in a Tinnitus Management Program to relieve patients suffering from tinnitus. The target population is primarily the adult population over 18 years of age.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
Registration Information
Registration Number
DE0506130
Registration Date
September 01, 2021
Retention Due Date
August 31, 2025
Product Owner
Short Name
Starkey Laboratories, Inc
Address
6700 Washington Avenue South, Eden Prairie, 55344, UNITED STATES, UNITED STATES
Registrant
Address
85 PLAYFAIR ROAD, TONG YUAN INDUSTRIAL BUILDING, #04-02, SINGAPORE 368000
Importer
Address
151 LORONG CHUAN, NEW TECH PARK, #03-01B, SINGAPORE 556741 151 LORONG CHUAN, NEW TECH PARK, #03-01B, SINGAPORE 556741
Model Information
Model Name(s)
Thrive App Thrive App Audibel Via AI 2400 BTE 13 Audibel Via AI 2000 BTE 13 Audibel Via AI 1600 BTE 13 Audibel Via AI 1200 BTE 13 Audibel Via AI 1000 BTE 13 Audibel Via AI 2400 RIC 312 Audibel Via AI 2000 RIC 312 Audibel Via AI 1600 RIC 312 Audibel Via AI 1200 RIC 312 Audibel Via AI 1000 RIC 312 Audibel Via AI 2400 RIC R Audibel Via AI 2000 RIC R Audibel Via AI 1600 RIC R Audibel Via AI 1200 RIC R Audibel Via AI 1000 RIC R Audibel Via AI 2400 mRIC 312 Audibel Via AI 2000 mRIC 312 Audibel Via AI 1600 mRIC 312 Audibel Via AI 1200 mRIC 312 Audibel Via AI 1000 mRIC 312 Audibel Via AI CROS RIC 312 Audibel Via AI CROS RIC R Audibel Via AI CROS BTE 13 AUDIBEL VIA EDGE AI 2400 BTE 13 AUDIBEL VIA EDGE AI 2400 MRIC 312 AUDIBEL VIA EDGE AI 2400 RIC 312 AUDIBEL VIA EDGE AI 2400 RIC R AUDIBEL VIA EDGE AI CROSBICROS BTE 13 AUDIBEL VIA EDGE AI CROSBICROS RIC 312 AUDIBEL VIA EDGE AI CROSBICROS RIC R SPIII20 Inspire X 2020.1 USB (Audible)
Model Identifier(s)
842318130792 842318130808 842318147486 842318147554 842318147622 842318147691 842318147776 842318148346 842318148421 842318148490 842318150424 842318150981 842318171467 842318171542 842318171610 842318171696 842318171788 842318171870 842318171962 842318172037 842318172112 842318172204 842318173379 842318175090 842318175816 842318177421 842318177452 842318177469 842318177476 842318177483 842318177490 842318177506 86448-010