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Yumizen H550 - SFDA Registration ME0000002480SFDAA00063

Access comprehensive regulatory information for Yumizen H550 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 ME0000002480SFDAA00063 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)
ME0000002480SFDAA00063
Yumizen H550
SFDA Registration: ME0000002480SFDAA00063
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Product Information

Hematology analyzer for use in clinical laboratories.

Product Use

The Yumizen H550 is a fully automated hematology analyzer for in-vitro diagnostic use in clinical laboratories. The instrument can operate in CBC mode and DIFF mode. it enumerates and identifies these parameter in K2-EDTA and K3-EDTA anticoagulated whole blood sample

Device Classification
Risk Class
General IVD(Others)
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000002480SFDAA00063
Authorization ID
GHTF-2018-3380
Status
Active
Expire Date
May 01, 2019
Manufacturer
Manufacturer Name
HORIBA ABX SAS
Model Information
Model ID(s)
Yumizen H550
Product Accessories

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