gudid
Primary ID: CE919553
UF-Fluorocell SF (UDI CE919553)
Manufactured by SYSMEX CORPORATION
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for UF-Fluorocell SF - Primary ID CE919553
Device Regulatory Overview
The UF-Fluorocell SF (Model/Catalog Number: CE919553) is a medical device manufactured by SYSMEX CORPORATION. This product is indexed under FDA Product Code / Category Classification GJH within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- CE919553
- Product Code / EMDN
- GJH
- Device Name
- UF-Fluorocell SF is used to mark formed elements in urine or in body fluids for determination of red blood cells, casts, etc. counts with the Sysmex fully automated urine particle analyzers. UF-Fluorocell SF is intended for use only in conjunction with Sysmex diluent UF-CELLPACK SF.
- Database Sync Date
- 2026-08-09 09:45:59
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of UF-Fluorocell SF?
The registered manufacturer of record for UF-Fluorocell SF is SYSMEX CORPORATION.
What is the Primary UDI-DI identifier for UF-Fluorocell SF?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is CE919553.
What classification code is assigned to this device?
This device is registered under product classification code GJH.
Similar Classification Devices (GJH)
Other Devices by SYSMEX CORPORATION
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