Saudi Arabia SFDA registration ME0000000644SFDAA00028
Automated Hematology Analyzer XN series Transportation Units SA-31
Saudi Arabia·Chemicals·Sysmex Corporation·General IVD(Others)ActiveProduct information
XN-3100 sampler to connect XN analyser with SP-50, capacity 100 samples
Product use
The XN series is an automated hematology analyzer for in vitro diagnostic use in clinical laboratories. Only human
blood, human body fluids or control blood should be run. Any other use is regarded as non-specified.
Use only the reagents and cleaning fluids mentioned in this manual.
If the instrument fails to function properly as a result of either the user's operation not specified in the manual or the
user's utilization of a program not specified by Sysmex, the product warranty would not apply.
Device classification
- Risk Class
- General IVD(Others)
- Product Category
- Chemicals
- Product Type
- IVD
Registration information
- Registration ID
- ME0000000644SFDAA00028
- Authorization ID
- GHTF-2018-0458
- Status
- Active
- Expire Date
- February 02, 2019
Manufacturer
- Manufacturer Name
- Sysmex Corporation
Model information
- Model ID(s)
- SA-31
Product accessories
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About this record
Access comprehensive regulatory information for Automated Hematology Analyzer XN series Transportation Units SA-31 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 ME0000000644SFDAA00028 and manufactured by Sysmex 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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