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Yumizen H1500 - SFDA Registration ME0000002480SFDAA00062

Access comprehensive regulatory information for Yumizen H1500 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 ME0000002480SFDAA00062 and manufactured by HORIBA ABX SAS.

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)
ME0000002480SFDAA00062
Yumizen H1500
SFDA Registration: ME0000002480SFDAA00062
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Product Information

Hematology analyzer for use in clinical laboratories.

Product Use

The Yumizen H1500 is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories

Device Classification
Risk Class
General IVD(Others)
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000002480SFDAA00062
Authorization ID
MDMA-1-2019-2385
Status
Active
Expire Date
May 27, 2025
Manufacturer
Manufacturer Name
HORIBA ABX SAS
Model Information
Model ID(s)
Yumizen H1500
Product Accessories

[{'tradeName': 'Yumizen P8000', 'description': 'interface between Laboratory Information System and instruments dedicated to generate results', 'gmdn': '43472'}]