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StatStrip Hb/Hct Meter - SFDA Registration ME0000005135SFDAA00035

Access comprehensive regulatory information for StatStrip Hb/Hct Meter 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 ME0000005135SFDAA00035 and manufactured by Nova Biomedical Corporation.

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)
ME0000005135SFDAA00035
StatStrip Hb/Hct Meter
SFDA Registration: ME0000005135SFDAA00035
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Product Information

Point-of-Care IVD Meter for the measurement of hemoglobin and hematocrit in whole blood

Product Use

"The StatStrip Hemoglobin and Hemotocrit Meter System is intended for point-of-care, in vitro diagnostic, use for the quantitative determination of hemoglobin and hematocrit in fresh capillary whole blood obtained from a fingerstick and venous whole blood. It is intended for multiple-patient use in a professional healthcare setting. The system should only be used with single-use, autodisabling lancing devices when performing a capillary fingerstick. Not for use with neonates."

Device Classification
Risk Class
General IVD(Others)
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000005135SFDAA00035
Authorization ID
MDMA-1-2019-3067
Status
Active
Expire Date
May 05, 2025
Manufacturer
Model Information
Model ID(s)
59759
Product Accessories

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