Saudi Arabia SFDA registration ME0000005135SFDAA00035
StatStrip Hb/Hct Meter
Saudi Arabia·Chemicals·Nova Biomedical Corporation·General IVD(Others)ActiveProduct 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
- Manufacturer Name
- Nova Biomedical Corporation
Model information
- Model ID(s)
- 59759
Product accessories
[]
About this record
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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