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Starkey NuEar Hearing Aids (ITE, Wireless, Digital) - HSA Registration DE0504555

Access comprehensive regulatory information for Starkey NuEar Hearing Aids (ITE, 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 DE0504555 and owned by Starkey Laboratories, Inc. The device was registered on June 04, 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
DE0504555
Starkey NuEar Hearing Aids (ITE, Wireless, Digital)
HSA Registration Number: DE0504555
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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 levelsappropriate 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
DE0504555
Registration Date
June 04, 2020
Retention Due Date
June 03, 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)
NUEAR CIRCA EDGE AI 2400 ITE R NUEAR CIRCA AI 2000 ITE R NUEAR CIRCA AI 1600 ITE R NUEAR CIRCA AI 1200 ITE R NUEAR CIRCA AI 1000 ITE R NUEAR CIRCA 2400 ITE R NUEAR CIRCA 2000 ITE R NUEAR CIRCA 1600 ITE R NUEAR CIRCA 1200 ITE R NUEAR CIRCA 1000 ITE R NUEAR CIRCA EDGE AI 2400 ITC R NUEAR CIRCA AI 2000 ITC R NUEAR CIRCA AI 1600 ITC R NUEAR CIRCA AI 1200 ITC R NUEAR CIRCA AI 1000 ITC R NUEAR CIRCA 2400 ITC R NUEAR CIRCA 2000 ITC R NUEAR CIRCA 1600 ITC R NUEAR CIRCA 1200 ITC R NUEAR CIRCA 1000 ITC R
Model Identifier(s)
63219-NUE 63221-NUE 63222-NUE 63223-NUE 63224-NUE 63225-NUE 63226-NUE 63227-NUE 63228-NUE 63229-NUE 63230-NUE 63232-NUE 63233-NUE 63234-NUE 63235-NUE 63236-NUE 63237-NUE 63238-NUE 63239-NUE 63240-NUE