Singapore HSA registration DE0506771
Starkey Starkey Evolv AI Hearing Aids (ITE, Wireless, Digital)
Singapore·CLASS B·Starkey Laboratories Inc.·Registered April 01, 2022Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ear, Nose & Throat
Registration information
- Registration Number
- DE0506771
- Registration Date
- April 01, 2022
- Retention Due Date
- March 31, 2026
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 STARKEY EVOLV AI 2000 CIC STARKEY EVOLV AI 1600 CIC STARKEY EVOLV AI 1200 CIC STARKEY EVOLV AI 1000 CIC STARKEY INSPIRE
- Model Identifier(s)
- 842318130792 842318130808 63311-SHT 63312-SHT 63313-SHT 63314-SHT 63315-SHT 86571-000
About this record
Access comprehensive regulatory information for Starkey Starkey Evolv AI 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 DE0506771 and owned by Starkey Laboratories Inc.. The device was registered on April 01, 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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