Singapore HSA registration DE0505338
Starkey MicroTech hearing aids (ITE, Non-wireless)
Singapore·CLASS B·Starkey Laboratories, Inc·Registered January 12, 2021Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ear, Nose & Throat
Registration information
- Registration Number
- DE0505338
- Registration Date
- January 12, 2021
- Retention Due Date
- January 11, 2026
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.
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)
- MICROTECH SUMMIT IQ 2400 ITC MICROTECH SUMMIT IQ 2400 ITE MICROTECH SUMMIT IQ 1600 ITC MICROTECH SUMMIT IQ 1600 ITE MICROTECH SUMMIT IQ 2000 ITC MICROTECH SUMMIT IQ 2000 ITE MICROTECH SUMMIT IQ 2400 CIC MICROTECH SUMMIT IQ 1600 CIC MICROTECH SUMMIT IQ 2000 CIC MICROTECH MICROLENS SYN IQ 2400 IIC MICROTECH MICROLENS SYN IQ 1600 IIC MICROTECH MICROLENS SYN IQ 2000 IIC MICROTECH SUMMIT IQ 1200 CIC MICROTECH SUMMIT IQ 1000 CIC MICROTECH SUMMIT IQ 1200 ITC MICROTECH SUMMIT IQ 1000 ITC MICROTECH SUMMIT IQ 1200 ITE MICROTECH SUMMIT IQ 1000 ITE Inspire X
- Model Identifier(s)
- 842318124098 842318124104 842318124210 842318124227 842318124333 842318124340 842318124920 842318125026 842318125125 842318125224 842318125323 842318125422 842318130129 842318130136 842318130143 842318130150 842318130181 842318130198 86448-004
About this record
Access comprehensive regulatory information for Starkey MicroTech hearing aids (ITE, Non-wireless) in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0505338 and owned by Starkey Laboratories, Inc. The device was registered on January 12, 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.
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