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Starkey Starkey Livio Hearing Aids (BTE, Wireless, Digital) - HSA Registration DE0504776

Access comprehensive regulatory information for Starkey Starkey Livio 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 DE0504776 and owned by Starkey Laboratories, Inc. The device was registered on August 05, 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.

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CLASS B
DE0504776
Starkey Starkey Livio Hearing Aids (BTE, Wireless, Digital)
HSA Registration Number: DE0504776
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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
DE0504776
Registration Date
August 05, 2020
Retention Due Date
August 04, 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 Starkey Livio AI 2400 BTE 13 Starkey Livio AI 2000 BTE 13 Starkey Livio AI 1600 BTE 13 Starkey Livio AI 1200 BTE 13 Starkey Livio AI 1000 BTE 13 Starkey Livio AI 2400 RIC 312 Starkey Livio AI 2000 RIC 312 Starkey Livio AI 1600 RIC 312 Starkey Livio AI 1200 RIC 312 Starkey Livio AI 1000 RIC 312 STARKEY LIVIO AI 2400 RIC R Starkey Livio AI 2000 RIC R Starkey Livio AI 1600 RIC R Starkey Livio AI 1200 RIC R Starkey Livio AI 1000 RIC R Starkey Livio AI 2400 mRIC 312 Starkey Livio AI 2000 mRIC 312 Starkey Livio AI 1600 mRIC 312 Starkey Livio AI 1200 mRIC 312 Starkey Livio AI 1000 mRIC 312 Starkey Livio AI CROS RIC 312 Starkey Livio AI CROS RIC R Starkey Livio AI CROS BTE 13 STARKEY LIVIO EDGE AI 2400 BTE 13 STARKEY LIVIO EDGE AI 2400 MRIC 312 STARKEY LIVIO EDGE AI 2400 RIC 312 STARKEY LIVIO EDGE AI 2400 RIC R STARKEY LIVIO EDGE AI CROSBICROS BTE 13 STARKEY LIVIO EDGE AI CROSBICROS RIC 312 STARKEY LIVIO EDGE AI CROSBICROS RIC R SPIII20 Inspire X 2020.1 USB (Livio)
Model Identifier(s)
842318130792 842318130808 842318147479 842318147547 842318147615 842318147684 842318147769 842318148339 842318148414 842318148483 842318150356 842318150912 842318171450 842318171535 842318171603 842318171689 842318171771 842318171863 842318171955 842318172020 842318172105 842318172198 842318173362 842318175083 842318175809 842318179319 842318179340 842318179357 842318179364 842318179371 842318179388 842318179395 86448-000