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DxH 500 - SFDA Registration ME0000000973SFDAA00005

Access comprehensive regulatory information for DxH 500 in the Saudi Arabia medical device market through Pure Global AI's free database. This General IVD(Others) device is registered with Saudi Arabia SFDA under registration number ME0000000973SFDAA00005 and manufactured by Beckman Coulter, Inc..

This page provides complete registration details including product category (Chemicals), manufacturer information, model details, and regulatory compliance data from the official Saudi Arabia SFDA medical device database. Pure Global AI offers free access to Saudi Arabia's complete medical device registry, helping global MedTech companies navigate SFDA regulations efficiently.

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General IVD(Others)
ME0000000973SFDAA00005
DxH 500
SFDA Registration: ME0000000973SFDAA00005
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Product Information

Automated Hematology Analyzer

Product Use

The DxH 500 identifies and enumerates the parameters: WBC, RBC, Hgb, Hct, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, LY%, LY#, MO%, MO#, NE%, NE#, EO%, EO#, BA%, BA# in whole-blood samples (venous and capillary) collected in K2EDTA and K3EDTA anticoagulants, and prediluted whole blood.

Device Classification
Risk Class
General IVD(Others)
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000000973SFDAA00005
Authorization ID
MDMA-1-2019-0911
Status
Active
Expire Date
April 09, 2025
Manufacturer
Manufacturer Name
Beckman Coulter, Inc.
Model Information
Model ID(s)
B40601
Product Accessories

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