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Singapore HSA registration DE0506132

Starkey NuEar CIRCA Hearing Aids (BTE, Wireless, Digital)

Singapore flagSingapore·CLASS B·Starkey Laboratories, Inc·Registered September 01, 2021
Device classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
Registration information
Registration Number
DE0506132
Registration Date
September 01, 2021
Retention Due Date
August 31, 2025
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.
Product Owner
Name
Starkey Laboratories, Inc
Short Name
Starkey Laboratories, Inc
Address
6700 Washington Avenue South, Eden Prairie, 55344, UNITED STATES, UNITED STATES
Registrant
Name
Starkey Hearing Technologies Singapore Pte Ltd
Address
85 PLAYFAIR ROAD, TONG YUAN INDUSTRIAL BUILDING, #04-02, SINGAPORE 368000
Importer
Name
STARKEY HEARING TECHNOLOGIES SINGAPORE PTE LTD THE HEARING SOLUTION COMPANY PTE. LTD.
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 NuEar Circa AI 2400 BTE 13 NuEar Circa AI 2000 BTE 13 NuEar Circa AI 1600 BTE 13 NuEar Circa AI 1200 BTE 13 NuEar Circa AI 1000 BTE 13 NuEar Circa AI 2400 RIC 312 NuEar Circa AI 2000 RIC 312 NuEar Circa AI 1600 RIC 312 NuEar Circa AI 1200 RIC 312 NuEar Circa AI 1000 RIC 312 NuEar Circa AI 2400 RIC R NuEar Circa AI 2000 RIC R NuEar Circa AI 1600 RIC R NuEar Circa AI 1200 RIC R NuEar Circa AI 1000 RIC R NuEar Circa AI 2400 mRIC 312 NuEar Circa AI 2000 mRIC 312 NuEar Circa AI 1600 mRIC 312 NuEar Circa AI 1200 mRIC 312 NuEar Circa AI 1000 mRIC 312 NuEar Circa AI CROS RIC 312 NuEar Circa AI CROS RIC R NuEar Circa AI CROS BTE 13 NUEAR CIRCA EDGE AI 2400 BTE 13 NUEAR CIRCA EDGE AI 2400 MRIC 312 NUEAR CIRCA EDGE AI 2400 RIC 312 NUEAR CIRCA EDGE AI 2400 RIC R NUEAR CIRCA EDGE AI CROSBICROS BTE 13 NUEAR CIRCA EDGE AI CROSBICROS RIC 312 NUEAR CIRCA EDGE AI CROSBICROS RIC R
Model Identifier(s)
842318130792 842318130808 842318147493 842318147561 842318147639 842318147707 842318147783 842318148353 842318148438 842318148506 842318150493 842318151056 842318171474 842318171559 842318171627 842318171702 842318171795 842318171887 842318171979 842318172044 842318172129 842318172211 842318173386 842318175106 842318175823 842318178879 842318178909 842318178916 842318178923 842318178930 842318178947 842318178954
About this record

Access comprehensive regulatory information for Starkey NuEar CIRCA 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 DE0506132 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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