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PENTRA XLR - SFDA Registration ME0000002480SFDAA00021

Access comprehensive regulatory information for PENTRA XLR 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 ME0000002480SFDAA00021 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)
ME0000002480SFDAA00021
PENTRA XLR
SFDA Registration: ME0000002480SFDAA00021
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Product Information

Hematology analyzer for testing of whole blood specimens.

Product Use

It is a fully automated hematology analyzer used for the in vitro diagnostic testing of whole blood specimens.The instrument can operate in: CBC mode (Cell Blood Count) DIFF mode (CBC + Differential count)

Device Classification
Risk Class
General IVD(Others)
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000002480SFDAA00021
Authorization ID
GHTF-2018-3380
Status
Active
Expire Date
May 01, 2019
Manufacturer
Manufacturer Name
HORIBA ABX SAS
Model Information
Model ID(s)
PENTRA XLR
Product Accessories

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