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HC-Calibrator - SFDA Registration ME0000008068SFDAA00352

Access comprehensive regulatory information for HC-Calibrator 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 ME0000008068SFDAA00352 and manufactured by HUMAN Gesellschaft fศ•r Biochemica & Diagnostica mbH.

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)
ME0000008068SFDAA00352
HC-Calibrator
SFDA Registration: ME0000008068SFDAA00352
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Product Information

Hematology Calibrator for HumaCount 30TS 60TS, 80TS and 5L

Product Use

to perform periodic calibration in order to generate accurate patient results. This calibrator is a stable, whole blood preparation that can be used to verify and adjust calibration of select hematology instruments.

Device Classification
Risk Class
General IVD(Others)
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000008068SFDAA00352
Authorization ID
GHTF-2018-2630
Status
Active
Expire Date
May 07, 2024
Model Information
Model ID(s)
17400/50
Product Accessories

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