Soundure

GUDID 06971094538448

Huizhou Jinghao Medical Technology Co., Ltd

Air-conduction hearing aid, behind-the-ear
Primary Device ID06971094538448
NIH Device Record Keyad59a94e-0ec4-47f7-9952-18be0feafc3f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSoundure
Version Model NumberJH-D260
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-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106971094538448 [Primary]

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 Date2025-09-23
Device Publish Date2025-09-15

On-Brand Devices [Soundure]

06971094538455JH-DW2ET
06971094538448JH-D260
06971094538431JH-D26AT

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