Singapore HSA registration DE0507055
Starkey Nuear Savant Al Hearing Aids (ITE, Digital)
Singapore·CLASS B·Starkey Laboratories Inc.·Registered July 06, 2022Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ear, Nose & Throat
Registration information
- Registration Number
- DE0507055
- Registration Date
- July 06, 2022
- Retention Due Date
- July 05, 2025
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.
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 NUEAR SAVANT AI 2400 CIC NW NUEAR SAVANT AI 2000 CIC NW NUEAR SAVANT AI 1600 CIC NW NUEAR SAVANT AI 1200 CIC NW NUEAR SAVANT AI 1000 CIC NW NUEAR SAVANT AI 2400 IIC NW NUEAR SAVANT AI 2000 IIC NW NUEAR SAVANT AI 1600 IIC NW NUEAR INSPIRE
- Model Identifier(s)
- 842318130792 842318130808 63322-NUE 63323-NUE 63324-NUE 63325-NUE 63326-NUE 63327-NUE 63328-NUE 63329-NUE 86571-500
About this record
Access comprehensive regulatory information for Starkey Nuear Savant 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 DE0507055 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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