Pure Global

Starkey MicroTech Essentia Hearing Aids (BTE, Wireless, Digital) - HSA Registration DE0506131

Access comprehensive regulatory information for Starkey MicroTech Essentia 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 DE0506131 and owned by Starkey Laboratories, Inc. The device was registered on September 01, 2021.

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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS B
DE0506131
Starkey MicroTech Essentia Hearing Aids (BTE, Wireless, Digital)
HSA Registration Number: DE0506131
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
Registration Information
Registration Number
DE0506131
Registration Date
September 01, 2021
Retention Due Date
August 31, 2025
Product Owner
Short Name
Starkey Laboratories, Inc
Address
6700 Washington Avenue South, Eden Prairie, 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 151 LORONG CHUAN, NEW TECH PARK, #03-01B, SINGAPORE 556741
Model Information
Model Name(s)
Thrive App Thrive App MICROTECH ESENTIA AI 2400 BTE 13 MICROTECH ESENTIA AI 2000 BTE 13 MICROTECH ESENTIA AI 1600 BTE 13 MICROTECH ESENTIA AI 1200 BTE 13 MICROTECH ESENTIA AI 1000 BTE 13 MICROTECH ESENTIA AI 2400 RIC 312 MICROTECH ESENTIA AI 2000 RIC 312 MICROTECH ESENTIA AI 1600 RIC 312 MICROTECH ESENTIA AI 1200 RIC 312 MICROTECH ESENTIA AI 1000 RIC 312 MICROTECH ESENTIA AI 2400 RIC R MICROTECH ESENTIA AI 2000 RIC R MICROTECH ESENTIA AI 1600 RIC R MICROTECH ESENTIA AI 1200 RIC R MICROTECH ESENTIA AI 1000 RIC R MICROTECH ESENTIA AI 2400 MRIC 312 MICROTECH ESENTIA AI 2000 MRIC 312 MICROTECH ESENTIA AI 1600 MRIC 312 MICROTECH ESENTIA AI 1200 MRIC 312 MICROTECH ESENTIA AI 1000 MRIC 312 MICROTECH ESENTIA AI CROSBICROS RIC 312 MICROTECH ESENTIA AI CROSBICROS RIC R MICROTECH ESENTIA AI CROSBICROS BTE 13 MICROTECH ESENTIA EDGE AI 2400 BTE 13 MICROTECH ESENTIA EDGE AI 2400 MRIC 312 MICROTECH ESENTIA EDGE AI 2400 RIC 312 MICROTECH ESENTIA EDGE AI 2400 RIC R MICROTECH ESENTIA EDGE AI CROSBICROS BTE 13 MICROTECH ESENTIA EDGE AI CROSBICROS RIC 312 MICROTECH ESENTIA EDGE AI CROSBICROS RIC R SPIII20 Inspire X 2020.1 USB (Microtech Essentia)
Model Identifier(s)
842318130792 842318130808 842318147516 842318147585 842318147653 842318147721 842318147806 842318148377 842318148452 842318148520 842318150639 842318151490 842318171498 842318171573 842318171641 842318171726 842318171818 842318171900 842318171993 842318172068 842318172143 842318172235 842318173409 842318175120 842318175847 842318178527 842318178558 842318178565 842318178572 842318178589 842318178596 842318178602 86448-004