Singapore HSA registration DE0507054
Starkey Starkey Evolv 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
- DE0507054
- 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 STARKEY EVOLV AI 2400 CIC NW STARKEY EVOLV AI 2000 CIC NW STARKEY EVOLV AI 1600 CIC NW STARKEY EVOLV AI 1200 CIC NW STARKEY EVOLV AI 1000 CIC NW STARKEY EVOLV AI 2400 IIC NW STARKEY EVOLV AI 2000 IIC NW STARKEY EVOLV AI 1600 IIC NW STARKEY INSPIRE
- Model Identifier(s)
- 842318130792 842318130808 63322-SHT 63323-SHT 63324-SHT 63325-SHT 63326-SHT 63327-SHT 63328-SHT 63329-SHT 86571-000
About this record
Access comprehensive regulatory information for Starkey Starkey Evolv 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 DE0507054 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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