GUDIDData
gudid Primary ID: BY990757

Automated Blood Coagulation Analyzer CS-5100 (UDI BY990757)

Manufactured by SYSMEX CORPORATION

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Automated Blood Coagulation Analyzer CS-5100 - Primary ID BY990757

Device Regulatory Overview

The Automated Blood Coagulation Analyzer CS-5100 (Model/Catalog Number: BY990757) is a medical device manufactured by SYSMEX CORPORATION. This product is indexed under FDA Product Code / Category Classification JPA within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
BY990757
Product Code / EMDN
JPA
Device Name
CS-5100 COMPLETE
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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Frequently Asked Questions

Who is the primary manufacturer of Automated Blood Coagulation Analyzer CS-5100?

The registered manufacturer of record for Automated Blood Coagulation Analyzer CS-5100 is SYSMEX CORPORATION.

What is the Primary UDI-DI identifier for Automated Blood Coagulation Analyzer CS-5100?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is BY990757.

What classification code is assigned to this device?

This device is registered under product classification code JPA.

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