Singapore HSA registration DE0509126
Starkey Signature Series In-the-Ear Hearing Aids (ITE,Non-Wireless, Digital)
Singapore·CLASS B·Starkey Laboratories Inc.·Registered April 01, 2024Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ear, Nose & Throat
Registration information
- Registration Number
- DE0509126
- Registration Date
- April 01, 2024
- 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. The Multiflex Tinnitus Technology is targeted for healthcare professionals, which are treating patients suffering from tinnitus, as well as conventional hearing disorders. The fitting of the Multiflex Tinnitus Technology must be done by a hearing professional participating in a Tinnitus Management Program.
Product Owner
- Short Name
- Starkey Laboratories Inc.
- Address
- 6700 Washington Avenue S,, Eden Prairie, Minnesota, 55344 United States, 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 My Starkey Starkey Pro Fit Fitting Software STARKEY SIGNATURE SERIES 24 CIC R NW STARKEY SIGNATURE SERIES 20 CIC R NW STARKEY SIGNATURE SERIES 16 CIC R NW STARKEY SIGNATURE SERIES 12 CIC R NW STARKEY SIGNATURE SERIES 24 IIC NW STARKEY SIGNATURE SERIES 20 IIC NW STARKEY SIGNATURE SERIES 16 IIC NW STARKEY SIGNATURE SERIES 24 CIC NW STARKEY SIGNATURE SERIES 20 CIC NW STARKEY SIGNATURE SERIES 16 CIC NW STARKEY SIGNATURE SERIES 12 CIC NW
- Model Identifier(s)
- 86701-000 P00000970 P00002130 P00002131 P00002132 P00002133 P00004173 P00004174 P00004175 P00004206 P00004207 P00004208 P00004209
About this record
Access comprehensive regulatory information for Starkey Signature Series In-the-Ear Hearing Aids (ITE,Non-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 DE0509126 and owned by Starkey Laboratories Inc.. The device was registered on April 01, 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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