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Starkey Starkey Evolv AI Hearing Aids (BTE, Wireless, Digital) - HSA Registration DE0506778

Access comprehensive regulatory information for Starkey Starkey Evolv 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 DE0506778 and owned by Starkey Laboratories Inc.. The device was registered on April 05, 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
DE0506778
Starkey Starkey Evolv AI Hearing Aids (BTE, Wireless, Digital)
HSA Registration Number: DE0506778
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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
DE0506778
Registration Date
April 05, 2022
Retention Due Date
April 04, 2026
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 STARKEY EVOLV AI 2400 BTE 13 PWRPLS STARKEY EVOLV AI 2400 BTE 13 PWRPLS STARKEY EVOLV AI 2400 BTE 13 PWRPLS STARKEY EVOLV AI 2400 BTE 13 PWRPLS STARKEY EVOLV AI 2400 BTE 13 PWRPLS STARKEY EVOLV AI 2400 BTE 13 PWRPLS STARKEY EVOLV AI 2400 BTE 13 PWRPLS STARKEY EVOLV AI 2000 BTE 13 PWRPLS STARKEY EVOLV AI 2000 BTE 13 PWRPLS STARKEY EVOLV AI 2000 BTE 13 PWRPLS STARKEY EVOLV AI 2000 BTE 13 PWRPLS STARKEY EVOLV AI 2000 BTE 13 PWRPLS STARKEY EVOLV AI 2000 BTE 13 PWRPLS STARKEY EVOLV AI 2000 BTE 13 PWRPLS STARKEY EVOLV AI 1600 BTE 13 PWRPLS STARKEY EVOLV AI 1600 BTE 13 PWRPLS STARKEY EVOLV AI 1600 BTE 13 PWRPLS STARKEY EVOLV AI 1600 BTE 13 PWRPLS STARKEY EVOLV AI 1600 BTE 13 PWRPLS STARKEY EVOLV AI 1600 BTE 13 PWRPLS STARKEY EVOLV AI 1600 BTE 13 PWRPLS STARKEY EVOLV AI 1200 BTE 13 PWRPLS STARKEY EVOLV AI 1200 BTE 13 PWRPLS STARKEY EVOLV AI 1200 BTE 13 PWRPLS STARKEY EVOLV AI 1200 BTE 13 PWRPLS STARKEY EVOLV AI 1200 BTE 13 PWRPLS STARKEY EVOLV AI 1200 BTE 13 PWRPLS STARKEY EVOLV AI 1200 BTE 13 PWRPLS STARKEY EVOLV AI 1000 BTE 13 PWRPLS STARKEY EVOLV AI 1000 BTE 13 PWRPLS STARKEY EVOLV AI 1000 BTE 13 PWRPLS STARKEY EVOLV AI 1000 BTE 13 PWRPLS STARKEY EVOLV AI 1000 BTE 13 PWRPLS STARKEY EVOLV AI 1000 BTE 13 PWRPLS STARKEY EVOLV AI 1000 BTE 13 PWRPLS STARKEY INSPIRE X 2021.0
Model Identifier(s)
842318130792 842318130808 63241-102 63241-105 63241-106 63241-110 63241-111 63241-112 63241-114 63245-102 63245-105 63245-106 63245-110 63245-111 63245-112 63245-114 63246-102 63246-105 63246-106 63246-110 63246-111 63246-112 63246-114 63247-102 63247-105 63247-106 63247-110 63247-111 63247-112 63247-114 63248-102 63248-105 63248-106 63248-110 63248-111 63248-112 63248-114 86571-000