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Singapore HSA registration DE0510258

Starkey Edge AI Hearing Aids (ITE, Wireless, Digital)

Singapore flagSingapore·CLASS B·Starkey Laboratories Inc.·Registered January 17, 2025
Device classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
Registration information
Registration Number
DE0510258
Registration Date
January 17, 2025
Retention Due Date
January 16, 2026
Product description
Air conduction hearing aids are wearable sound-amplifying devices that are intended to compensate for impaired hearing.
Product Owner
Name
Starkey Laboratories Inc.
Short Name
Starkey Laboratories Inc.
Address
6700 Washington Avenue S,, Eden Prairie, Minnesota, 55344 United States, UNITED STATES
Registrant
Name
Starkey Hearing Technologies Singapore Pte Ltd
Address
85 PLAYFAIR ROAD, TONG YUAN INDUSTRIAL BUILDING, #04-02, SINGAPORE 368000
Importer
Name
STARKEY HEARING TECHNOLOGIES SINGAPORE PTE LTD
Address
151 LORONG CHUAN, NEW TECH PARK, #03-01B, SINGAPORE 556741
Model information
Model Name(s)
STARKEY EDGE AI 24 CIC STARKEY EDGE AI 20 CIC STARKEY EDGE AI 16 CIC STARKEY EDGE AI 12 CIC Starkey Edge AI 24 ITE R Starkey Edge AI 20 ITE R Starkey Edge AI 16 ITE R Starkey Edge AI 12 ITE R STARKEY EDGE AI 24 ITC R STARKEY EDGE AI 20 ITC R STARKEY EDGE AI 16 ITC R STARKEY EDGE AI 12 ITC R STARKEY EDGE AI 24 HS R STARKEY EDGE AI 20 HS R STARKEY EDGE AI 16 HS R STARKEY EDGE AI 12 HS R My Starkey - iOS My Starkey - Android Starkey Pro Fit
Model Identifier(s)
72096-SHT 72097-SHT 72098-SHT 72099-SHT 72121-SHT 72123-SHT 72124-SHT 72125-SHT 72128-SHT 72129-SHT 72130-SHT 72131-SHT 72132-SHT 72134-SHT 72135-SHT 72136-SHT My Starkey -IOS My Starkey -Android Pro Fit
About this record

Access comprehensive regulatory information for Starkey Edge 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 DE0510258 and owned by Starkey Laboratories Inc.. The device was registered on January 17, 2025.

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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