Singapore HSA registration DE0509119
Starkey Genesis Hearing Aids (CIC, Wireless, Digital)
Singapore·CLASS B·Starkey Laboratories Inc.·Registered March 27, 2024Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ear, Nose & Throat
Registration information
- Registration Number
- DE0509119
- Registration Date
- March 27, 2024
- Retention Due Date
- March 26, 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 toprofound. 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
Model information
- Model Name(s)
- STARKEY GENESIS AI 24 CIC 312 STARKEY GENESIS AI 20 CIC 312 STARKEY GENESIS AI 16 CIC 312 STARKEY GENESIS AI 12 CIC 312
- Model Identifier(s)
- 72031-SHT 72032-SHT 72033-SHT 72034-SHT
About this record
Access comprehensive regulatory information for Starkey Genesis Hearing Aids (CIC, 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 DE0509119 and owned by Starkey Laboratories Inc.. The device was registered on March 27, 2024.
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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