Home GUDID 06970289035861 Hetaida
Primary DI 06970289035861
Brand Hetaida
Company Hetaida Technology Co., Ltd
Model HTD6101US
Device description Behind-the-Ear Hearing Aid
Published 2025-05-12
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true Product Codes# Code, Name table Code Name ESD Hearing Aid, Air Conduction
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ESD Hearing Aid, Air-Conduction, Prescription Ear, Nose, Throat 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 16970289035868 Package GS1 60 In Commercial Distribution 06970289035861 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 16970289035868 16970289035868 06970289035861 06970289035861 6970289035861
GMDN Terms# Term, Definition table Term Definition Air-conduction hearing aid, receiver-in-the-ear A battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It consists of a microphone or microphones and an amplifier in a case behind-the-ear (BTE) connected, via a wire, to a receiver (speaker) in the outer ear [receiver-in-the-ear (RITE)]. The microphone(s) receives sound waves and converts them into electrical signals which are increased by the amplifier and sent as sound waves, by the speaker, to the eardrum. The device is used for mild to profound hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Handling Environment Humidity 15 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity Handling Environment Temperature -10 Degrees Celsius 40 Degrees Celsius Storage Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Storage Environment Humidity 0 Percent (%) Relative Humidity 93 Percent (%) Relative Humidity Storage Environment Temperature -40 Degrees Celsius 55 Degrees Celsius
Regulatory Flags# DUNS number 544474402 Device count 1 Premarket exempt true Lot or batch true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07613389772838 ampli-mini I 3 5P CIC-10 NWL PH Sonova AG ESD 2024-11-12 07613389772845 ampli-mini I 2 5P CIC-10 NWL PH Sonova AG ESD 2024-11-12 07613389772920 MEMINI I 4 5P CIC-10 NWL PH Sonova AG ESD 2024-11-12 07613389772937 MEMINI I 3 5P CIC-10 NWL PH Sonova AG ESD 2024-11-12 EDET038421 luxaprint 3D shell white 500g DETAX GmbH ESD 2024-08-28 06945936704070 Nano Xiamen New Sound Technology Co., Ltd. ESD 2024-05-21 06945936704087 Nano Xiamen New Sound Technology Co., Ltd. ESD 2024-05-21 16945936703773 Newsound Xiamen New Sound Technology Co., Ltd. ESD 2024-01-19 06945936703776 Newsound Xiamen New Sound Technology Co., Ltd. ESD 2024-01-19 00810126190000 Audina Audina Hearing Instruments, Inc. ESD 2023-01-26 00810126190017 Audina Audina Hearing Instruments, Inc. ESD 2023-01-26 00810126190024 Audina Audina Hearing Instruments, Inc. ESD 2023-01-26 00810126190031 Audina Audina Hearing Instruments, Inc. ESD 2023-01-26 00810126190048 Audina Audina Hearing Instruments, Inc. ESD 2023-01-26 00810126190055 Audina Audina Hearing Instruments, Inc. ESD 2023-01-26 00810126190062 Audina Audina Hearing Instruments, Inc. ESD 2023-01-26 00810126190079 Audina Audina Hearing Instruments, Inc. ESD 2023-01-26 00810126190086 Audina Audina Hearing Instruments, Inc. ESD 2023-01-26 00810126190093 Audina Audina Hearing Instruments, Inc. ESD 2023-01-26 00810126190109 Audina Audina Hearing Instruments, Inc. ESD 2023-01-26 00810126190116 Audina Audina Hearing Instruments, Inc. ESD 2023-01-26 00810126190123 Audina Audina Hearing Instruments, Inc. ESD 2023-01-26 00810126190130 Audina Audina Hearing Instruments, Inc. ESD 2023-01-26 00810126190147 Audina Audina Hearing Instruments, Inc. ESD 2023-01-26 00810126190154 Audina Audina Hearing Instruments, Inc. ESD 2023-01-26 00810126190161 Audina Audina Hearing Instruments, Inc. ESD 2023-01-26 00810126190178 Audina Audina Hearing Instruments, Inc. ESD 2023-01-26 00810126190185 Audina Audina Hearing Instruments, Inc. ESD 2023-01-26 00810126190192 Audina Audina Hearing Instruments, Inc. ESD 2023-01-26 00810126190208 Audina Audina Hearing Instruments, Inc. ESD 2023-01-26
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