GUDIDData
gudid Primary ID: AP795756

Automated Hematology Analyzer XN series XN-10 (UDI AP795756)

Manufactured by SYSMEX CORPORATION

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Automated Hematology Analyzer XN series XN-10 - Primary ID AP795756

Device Regulatory Overview

The Automated Hematology Analyzer XN series XN-10 (Model/Catalog Number: AP795756) is a medical device manufactured by SYSMEX CORPORATION. This product is indexed under FDA Product Code / Category Classification GKZ within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
AP795756
Product Code / EMDN
GKZ
Device Name
XN-10 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 Hematology Analyzer XN series XN-10?

The registered manufacturer of record for Automated Hematology Analyzer XN series XN-10 is SYSMEX CORPORATION.

What is the Primary UDI-DI identifier for Automated Hematology Analyzer XN series XN-10?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is AP795756.

What classification code is assigned to this device?

This device is registered under product classification code GKZ.

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