Star Bio

GUDID 06977382490023

Hearing aid

Star Bio Co.,Ltd

Air-conduction hearing aid, in-the-ear
Primary Device ID06977382490023
NIH Device Record Keyb86fbf6f-9c60-4e84-99fd-e0a783b5734f
Commercial Distribution StatusIn Commercial Distribution
Brand NameStar Bio
Version Model Number-
Company DUNS704479785
Company NameStar Bio 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 Numberfalse
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
GS106977382490023 [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 Date2024-05-20
Device Publish Date2024-05-11

On-Brand Devices [Star Bio]

06977382490047ScienlodicSciContour Body/Skin, SciVive Hair+BodySciTheraRecover,BioEpicPanel,SB012SB360, led ma
06977382490023Hearing aid
06977382490016Manual Stethoscope

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