FDA UDI In Commercial Distribution 🇺🇸 United States

Yumizen H2500

DI: 03610230009444 · Model: 1300102147 · HORIBA ABX SAS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Yumizen H2500
Primary DI
03610230009444
Version / Model
1300102147
Company Name
HORIBA ABX SAS
Labeler DUNS
273647420
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-11-29
Public Version
2
Public Version Date
2025-12-08
Public Version Status
Update
Public Device Record Key
2f8b6604-b5fb-40bf-8901-7ed554325a48

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
GKZ Counter, Differential Cell

GMDN Terms

Code Name
35476 Haematological cell analyser IVD

Identifiers

Type ID
Primary 03610230009444