FDA.report

KLARIQ

Primary DI
06971094538738
Brand
KLARIQ
Company
Huizhou Jinghao Medical Technology Co., Ltd
Model
JH-A26A
Published
2026-05-26
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

Related Records

Product Codes

CodeName
QUFHearing Aid, Air-Conduction, Over The Counter

Product Code Classifications

CodeDeviceSpecialtyClass
QUFHearing Aid, Air-Conduction, Over The CounterEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06971094538738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06971094538738069710945387386971094538738

GMDN Terms

TermDefinition
Air-conduction hearing aid, in-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 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
547508199
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
06971094538721KLARIQJH-A2602026-05-26
06971094538639Spade & CoJH-A19A2026-03-24
06971094538615GIATATHAJH-A19A2026-03-20
06971094538585Bachgold JH-A2602026-02-05
06971094538561HARMONIXJH-A32E2026-01-20
06971094538530LITOULFJH-A2602025-12-19
06971094539483JINGHAOJH-A26A2025-12-08
16971094538506NacenacyJH-DW2ET2025-12-01
16971094538513Nacenacy VillearJH-DW2ET2025-12-01
06971094539452JINGHAOJH-A2602025-09-24
06971094538431SoundureJH-D26AT2025-09-15
06971094538448SoundureJH-D2602025-09-15
06971094538455SoundureJH-DW2ET2025-09-15
06971094538424BATSTRKSJH-D26AT2025-09-01
06971094538387AOLIGIJH-A17BT2025-08-05
06971094538394AOLIGIJH-A2602025-08-05
16971094538346KMBJH-A26A2025-08-01
16971094538339Sharper ImageJH-D26AT2025-07-17
16971094538292SEEDEARJH-A2602025-07-01
16971094539442WuveeJH-A2602025-06-26

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06971094538721KLARIQHuizhou Jinghao Medical Technology Co., LtdQUF2026-05-26
06971094538639Spade & CoHuizhou Jinghao Medical Technology Co., LtdQUF2026-03-24
06971094538615GIATATHAHuizhou Jinghao Medical Technology Co., LtdQUF2026-03-20
06971094538585Bachgold Huizhou Jinghao Medical Technology Co., LtdQUF2026-02-05
06979053570034UltrotingShenzhen Magnet Technology Co., LtdQUF2026-01-21
06979053570041UltrotingShenzhen Magnet Technology Co., LtdQUF2026-01-21
06971094538530LITOULFHuizhou Jinghao Medical Technology Co., LtdQUF2025-12-19
06978898058011Viva HearShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06978898058028Viva HearShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06978898058035Viva HearShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06978898058042Xpect VisionShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06978898058059Xpect VisionShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06978898058066Xpect VisionShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06975958550010MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550119MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550225MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550232MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550249MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550256MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550263MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550270MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550287MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550294MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550300MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550324MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550331MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550362MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550379MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550386MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09
06975958550676MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09