Singapore HSA registration DE0505008
Starkey Livio Rechargeable Hearing Aids (BTE, Wireless, Digital)
Singapore·CLASS B·Starkey Laboratories, Inc·Registered October 07, 2020Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ear, Nose & Throat
Registration information
- Registration Number
- DE0505008
- Registration Date
- October 07, 2020
- Retention Due Date
- October 06, 2025
Product description
An air conduction hearing aid is a wearable sound-amplifying device that is 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 South, 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 LIVIO 2400 BTE R STARKEY LIVIO 2000 BTE R STARKEY LIVIO 1600 BTE R STARKEY LIVIO 1200 BTE R STARKEY LIVIO 1000 BTE R STARKEY LIVIO AI 2400 BTE R STARKEY LIVIO AI 2000 BTE R STARKEY LIVIO AI 1600 BTE R STARKEY LIVIO AI 1200 BTE R STARKEY LIVIO AI 1000 BTE R STARKEY LIVIO EDGE AI 2400 BTE R Inspire (Livio) Inspire (Livio)
- Model Identifier(s)
- 842318130792 842318130808 842318176868 842318176899 842318176929 842318176974 842318177001 842318177032 842318177063 842318177094 842318177124 842318177155 842318179326 86448-000 86449-000
About this record
Access comprehensive regulatory information for Starkey Livio Rechargeable Hearing Aids (BTE, 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 DE0505008 and owned by Starkey Laboratories, Inc. The device was registered on October 07, 2020.
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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