NewHear

GUDID 16971094538100

Huizhou Jinghao Medical Technology Co., Ltd

Air-conduction hearing aid, behind-the-ear
Primary Device ID16971094538100
NIH Device Record Key4973587c-6315-4a67-9888-5fc6f576758b
Commercial Distribution StatusIn Commercial Distribution
Brand NameNewHear
Version Model NumberJH-D26AT
Company DUNS547508199
Company NameHuizhou Jinghao Medical Technology Co., Ltd
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106971094538103 [Primary]
GS116971094538100 [Package]
Contains: 06971094538103
Package: [50 Units]
In Commercial Distribution

FDA Product Code

QUFHearing Aid, Air-Conduction, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-23
Device Publish Date2025-04-15

Devices Manufactured by Huizhou Jinghao Medical Technology Co., Ltd

16971094538100 - NewHear2025-04-23
16971094538100 - NewHear2025-04-23
16971094538117 - BIBIED2025-04-22
16971094539428 - JINGHAO2025-04-21
06971094539414 - JINGHAO2025-04-11
16971094538087 - OXILINE2025-04-01
16971094538094 - OXILINE2025-04-01
16971094538025 - equate2025-03-24
16971094538018 - Premium health2025-03-21

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