URIGHT Hemoglobin A1c Analyzer

GUDID 04713106028187

TAIDOC TECHNOLOGY CORPORATION

Glycated haemoglobin (HbA1C) analyser IVD
Primary Device ID04713106028187
NIH Device Record Keyd3f9f6f7-3d98-4c31-a89b-dac1cebe59cd
Commercial Distribution StatusIn Commercial Distribution
Brand NameURIGHT Hemoglobin A1c Analyzer
Version Model NumberTD-4611
Company DUNS658530993
Company NameTAIDOC TECHNOLOGY CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
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
GS104713106028187 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-03
Device Publish Date2025-03-26

Devices Manufactured by TAIDOC TECHNOLOGY CORPORATION

04713106028187 - URIGHT Hemoglobin A1c Analyzer2025-04-03
04713106028187 - URIGHT Hemoglobin A1c Analyzer2025-04-03
04710636640162 - TD-THIN Sterile Lancets (100pcs/box)2023-09-08
04710469873973 - CLEVER TD-1242 FOREHEAD THERMOMETER2021-11-05
04717095034143 - MbH Fingertip Pulse Oximeter2020-05-25
04710469873409 - Forehead Thermometer TD-12612020-02-28

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