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Starkey Audibel ARC Al Hearing Aids (ITE, Digital) - HSA Registration DE0507056

Access comprehensive regulatory information for Starkey Audibel ARC Al Hearing Aids (ITE, 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 DE0507056 and owned by Starkey Laboratories Inc.. The device was registered on July 06, 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.

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CLASS B
DE0507056
Starkey Audibel ARC Al Hearing Aids (ITE, Digital)
HSA Registration Number: DE0507056
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Product Description

An air conduction hearing aid is a wearable sound amplifying device 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
DE0507056
Registration Date
July 06, 2022
Retention Due Date
July 05, 2025
Product Owner
Short Name
Starkey Laboratories Inc.
Address
6700 Washington Avenue S, Eden Prairie, Minnesota 55344, 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 ARC AI 2400 CIC NW AUDIBEL ARC AI 2000 CIC NW AUDIBEL ARC AI 1600 CIC NW AUDIBEL ARC AI 1200 CIC NW AUDIBEL ARC AI 1000 CIC NW AUDIBEL ARC AI 2400 IIC NW AUDIBEL ARC AI 2000 IIC NW AUDIBEL ARC AI 1600 IIC NW AUDIBEL INSPIRE
Model Identifier(s)
842318130792 842318130808 63322-ABL 63323-ABL 63324-ABL 63325-ABL 63326-ABL 63327-ABL 63328-ABL 63329-ABL 86571-010