Home GUDID 06977352080438 ELEHEAR
Primary DI 06977352080438
Brand ELEHEAR
Company ELEHEAR Inc.
Model FC04
Device description Hearing aids
Published 2025-12-31
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 QUG Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QUG Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter Ear, Nose, Throat 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 06977352080438 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 06977352080438 06977352080438 6977352080438
GMDN Terms# Term, Definition table Term Definition Air-conduction hearing aid, 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 typically consists of a miniature microphone, amplifier, and speaker (receiver) contained in a case that fits completely inside the outer ear (concha) [in-the-ear (ITE)]. 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. The device is used for mild to severe hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.
Regulatory Flags# DUNS number 699441039 Device count 1 Premarket exempt true Serial number true Manufacturing date on label true Expiration 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 06980134820016 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820023 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820030 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820047 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820054 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820061 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820078 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820085 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820092 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820108 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820115 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820122 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820139 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820146 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820153 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820160 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820177 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820184 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820191 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820207 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820214 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820221 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820238 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820245 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820252 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820269 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820276 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06980134820283 n/a Blue Deer Medical Equipment (guangdong) Co., Ltd. QUG 2026-06-09 06973967150658 Eara Xiamen Vienatone Medical Technology Co., Ltd. QUG 2026-05-19 06971094538677 AntOkay Huizhou Jinghao Medical Technology Co., Ltd QUG 2026-05-01