Home GUDID 06974308960011 Retone
Primary DI 06974308960011
Brand Retone
Company Xiamen Retone Hearing Technology Co., Ltd
Model K218P
Published 2025-01-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name ESD Hearing Aid, Air-Conduction, Prescription
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 06974308960011 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 06974308960011 06974308960011 6974308960011
GMDN Terms# Term, Definition table Term Definition Air-conduction hearing aid, behind-the-ear A battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a microphone, an amplifier, and a speaker (receiver) contained in a case worn behind-the-ear (BTE). The microphone 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 through an earmould that fits inside the outer ear or a tube in the ear canal. 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.
Regulatory Flags# DUNS number 544329913 Device count 1 Premarket exempt true Serial number true Manufacturing date on label 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