FDA.reportPublic FDA data

n/a

Primary DI
06980134820023
Brand
n/a
Company
Blue Deer Medical Equipment (guangdong) Co., Ltd.
Model
DR6401
Device description
This device is a wearable RIC/BTE hearing aid, intended for hearing impaired individuals to assist daily listening and speech communication. It supports Bluetooth music streaming, APP self-tuning and remote fitting, and adopts 16-channel DSP intelligent noise reduction technology to improve sound clarity and speech recognition, featuring comfortable wearing, long battery life and simple operation.
Published
2026-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
QUGHearing Aid, Air-Conduction With Wireless Technology, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QUGHearing Aid, Air-Conduction With Wireless Technology, Over The CounterEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06980134820023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06980134820023069801348200236980134820023

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, behind-the-earA 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
456587027
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06980134820016n/aBD-B101A2026-06-09
06980134820030n/aBD-I101A2026-06-09
06980134820047n/aRC07-022026-06-09
06980134820054n/aE082026-06-09
06980134820061n/aBD-B1022026-06-09
06980134820078n/aBD-E101A2026-06-09
06980134820085n/aBD-E1012026-06-09
06980134820092n/aBD-E1022026-06-09
06980134820108n/aBD-I102A2026-06-09
06980134820115n/aBD-B1012026-06-09
06980134820122n/aBD-S1022026-06-09
06980134820139n/aBD-S1012026-06-09
06980134820146n/aBD-B1042026-06-09
06980134820153n/aBD-C1032026-06-09
06980134820160n/aBD-C1032026-06-09
06980134820177n/aBD-C1012026-06-09
06980134820184n/aBD-C1012026-06-09
06980134820191n/aBD-N101A2026-06-09
06980134820207n/aBD-B1052026-06-09
06980134820214n/aFi62026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08056262819890nuance audioLUXOTTICA GROUP SPAQUG2026-07-31
08056262856789nuance audioLUXOTTICA GROUP SPAQUG2026-07-31
06980305290013CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290020CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290037CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290044CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290068CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290082CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290099CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290105CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290112CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290129CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980134820016n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820030n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820047n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820054n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820061n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820078n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820085n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820092n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820108n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820115n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820122n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820139n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820146n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820153n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820160n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820177n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820184n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820191n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09