Yumizen H2500

GUDID 03610230009444

HORIBA ABX SAS

Haematological cell analyser IVD
Primary Device ID03610230009444
NIH Device Record Key2f8b6604-b5fb-40bf-8901-7ed554325a48
Commercial Distribution StatusIn Commercial Distribution
Brand NameYumizen H2500
Version Model Number1300102147
Company DUNS273647420
Company NameHORIBA ABX SAS
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
GS103610230009444 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GKZCounter, Differential Cell

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-09
Device Publish Date2024-11-29

On-Brand Devices [Yumizen H2500]

036102300094511300102148
036102300094441300102147

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