Singapore HSA registration DE0506676
Starkey NuEar Circa Rechargeable Hearing Aids (BTE, Wireless, Digital)
Singapore·CLASS B·Starkey Laboratories, Inc·Registered February 23, 2022Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ear, Nose & Throat
Registration information
- Registration Number
- DE0506676
- Registration Date
- February 23, 2022
- Retention Due Date
- February 22, 2026
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
- Short Name
- Starkey Laboratories, Inc
- Address
- 6700 Washington Avenue South, 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 NUEAR CIRCA 1000 BTE R NUEAR CIRCA 1200 BTE R NUEAR CIRCA 1600 BTE R NUEAR CIRCA 2000 BTE R NUEAR CIRCA 2400 BTE R NUEAR CIRCA AI 1000 BTE R NUEAR CIRCA AI 1200 BTE R NUEAR CIRCA AI 1600 BTE R NUEAR CIRCA AI 2000 BTE R NUEAR CIRCA AI 2400 BTE R NUEAR CIRCA EDGE AI 2400 BTE R
- Model Identifier(s)
- 842318130792 842318130808 842318178626 842318178640 842318178664 842318178688 842318178701 842318178725 842318178749 842318178763 842318178787 842318178800 842318178886
About this record
Access comprehensive regulatory information for Starkey NuEar Circa Rechargeable 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 DE0506676 and owned by Starkey Laboratories, Inc. The device was registered on February 23, 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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