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Starkey Starkey Genesis AI Hearing Aids (BTE, Wireless, Digital) - HSA Registration DE0508684

Access comprehensive regulatory information for Starkey Starkey Genesis AI 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 DE0508684 and owned by Starkey Laboratories Inc.. The device was registered on November 22, 2023.

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
DE0508684
Starkey Starkey Genesis AI Hearing Aids (BTE, Wireless, Digital)
HSA Registration Number: DE0508684
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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 Multi flex 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
DE0508684
Registration Date
November 22, 2023
Retention Due Date
November 21, 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)
STARKEY GENESIS AI 24 RIC RT STARKEY GENESIS AI 24 RIC RT STARKEY GENESIS AI 24 RIC RT STARKEY GENESIS AI 24 RIC RT STARKEY GENESIS AI 24 RIC RT STARKEY GENESIS AI 24 RIC RT STARKEY GENESIS AI 24 RIC RT STARKEY GENESIS AI 24 MRIC R STARKEY GENESIS AI 24 MRIC R STARKEY GENESIS AI 24 MRIC R STARKEY GENESIS AI 24 MRIC R STARKEY GENESIS AI 24 MRIC R STARKEY GENESIS AI 24 MRIC R STARKEY GENESIS AI 24 MRIC R STARKEY GENESIS AI 20 RIC RT STARKEY GENESIS AI 20 RIC RT STARKEY GENESIS AI 20 RIC RT STARKEY GENESIS AI 20 RIC RT STARKEY GENESIS AI 20 RIC RT STARKEY GENESIS AI 20 RIC RT STARKEY GENESIS AI 20 RIC RT STARKEY GENESIS AI 16 RIC RT STARKEY GENESIS AI 16 RIC RT STARKEY GENESIS AI 16 RIC RT STARKEY GENESIS AI 16 RIC RT STARKEY GENESIS AI 16 RIC RT STARKEY GENESIS AI 16 RIC RT STARKEY GENESIS AI 16 RIC RT STARKEY GENESIS AI 12 RIC RT STARKEY GENESIS AI 12 RIC RT STARKEY GENESIS AI 12 RIC RT STARKEY GENESIS AI 12 RIC RT STARKEY GENESIS AI 12 RIC RT STARKEY GENESIS AI 12 RIC RT STARKEY GENESIS AI 12 RIC RT STARKEY GENESIS AI 20 MRIC R STARKEY GENESIS AI 20 MRIC R STARKEY GENESIS AI 20 MRIC R STARKEY GENESIS AI 20 MRIC R STARKEY GENESIS AI 20 MRIC R STARKEY GENESIS AI 20 MRIC R STARKEY GENESIS AI 20 MRIC R STARKEY GENESIS AI 16 MRIC R STARKEY GENESIS AI 16 MRIC R STARKEY GENESIS AI 16 MRIC R STARKEY GENESIS AI 16 MRIC R STARKEY GENESIS AI 16 MRIC R STARKEY GENESIS AI 16 MRIC R STARKEY GENESIS AI 16 MRIC R STARKEY GENESIS AI 12 MRIC R STARKEY GENESIS AI 12 MRIC R STARKEY GENESIS AI 12 MRIC R STARKEY GENESIS AI 12 MRIC R STARKEY GENESIS AI 12 MRIC R STARKEY GENESIS AI 12 MRIC R STARKEY GENESIS AI 12 MRIC R STARKEY GENESIS AI CROS RIC RT STARKEY GENESIS AI CROS RIC RT STARKEY GENESIS AI CROS RIC RT STARKEY GENESIS AI CROS RIC RT STARKEY GENESIS AI CROS RIC RT STARKEY GENESIS AI CROS RIC RT STARKEY GENESIS AI CROS RIC RT STARKEY GENESIS AI 24 RIC 312 STARKEY GENESIS AI 24 RIC 312 STARKEY GENESIS AI 24 RIC 312 STARKEY GENESIS AI 24 RIC 312 STARKEY GENESIS AI 24 RIC 312 STARKEY GENESIS AI 24 RIC 312 STARKEY GENESIS AI 24 RIC 312 STARKEY GENESIS AI 20 RIC 312 STARKEY GENESIS AI 20 RIC 312 STARKEY GENESIS AI 20 RIC 312 STARKEY GENESIS AI 20 RIC 312 STARKEY GENESIS AI 20 RIC 312 STARKEY GENESIS AI 20 RIC 312 STARKEY GENESIS AI 20 RIC 312 STARKEY GENESIS AI 16 RIC 312 STARKEY GENESIS AI 16 RIC 312 STARKEY GENESIS AI 16 RIC 312 STARKEY GENESIS AI 16 RIC 312 STARKEY GENESIS AI 16 RIC 312 STARKEY GENESIS AI 16 RIC 312 STARKEY GENESIS AI 16 RIC 312 STARKEY GENESIS AI 12 RIC 312 STARKEY GENESIS AI 12 RIC 312 STARKEY GENESIS AI 12 RIC 312 STARKEY GENESIS AI 12 RIC 312 STARKEY GENESIS AI 12 RIC 312 STARKEY GENESIS AI 12 RIC 312 STARKEY GENESIS AI 12 RIC 312 My Starkey -Android My Starkey -IOS Starkey Pro Fit
Model Identifier(s)
63191-123 63191-131 63191-138 63191-139 63191-140 63191-141 63191-143 63197-123 63197-131 63197-138 63197-139 63197-140 63197-141 63197-143 63316-123 63316-131 63316-138 63316-139 63316-140 63316-141 63316-143 63317-123 63317-131 63317-138 63317-139 63317-140 63317-141 63317-143 63318-123 63318-131 63318-138 63318-139 63318-140 63318-141 63318-143 63319-123 63319-131 63319-138 63319-139 63319-140 63319-141 63319-143 63320-123 63320-131 63320-138 63320-139 63320-140 63320-141 63320-143 63321-123 63321-131 63321-138 63321-139 63321-140 63321-141 63321-143 63332-123 63332-131 63332-138 63332-139 63332-140 63332-141 63332-143 63338-123 63338-131 63338-138 63338-139 63338-140 63338-141 63338-143 63344-123 63344-131 63344-138 63344-139 63344-140 63344-141 63344-143 63345-123 63345-131 63345-138 63345-139 63345-140 63345-141 63345-143 63346-123 63346-131 63346-138 63346-139 63346-140 63346-141 63346-143 My Starkey -Android My Starkey -IOS Pro Fit