My Yodoc

GUDID 08800068200020

S-CONNECT CO.,LTD

Urine analyser IVD, point-of-care
Primary Device ID08800068200020
NIH Device Record Keya88c8fbe-ec45-4480-a65b-2cbf622e9ba0
Commercial Distribution StatusIn Commercial Distribution
Brand NameMy Yodoc
Version Model NumberSYD-M10PBBK
Company DUNS688835925
Company NameS-CONNECT CO.,LTD
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS108800068200020 [Primary]

FDA Product Code

KQOAutomated Urinalysis System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-20
Device Publish Date2020-04-10

On-Brand Devices [My Yodoc]

08800068200006SYD-M10PBBK
08800068200020SYD-M10PBBK

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