Saudi Arabia SFDA registration ME0000000973SFDAA00014
DxH 520
Product information
Automated Hematology Analyzer
Product use
The DxH 520 is a quantitative, multi-parameter, automated hematology analyzer for in vitro
diagnostic use in clinical laboratories; including hospital, reference, and physician's office
laboratories. It is used to identify the normal patient with normal system-generated parameters
from patients with abnormal parameters and/or flags that require additional studies.
Device classification
- Risk Class
- General IVD(Others)
- Product Category
- Chemicals
- Product Type
- IVD
Registration information
- Registration ID
- ME0000000973SFDAA00014
- Authorization ID
- MDMA-1-2019-0911
- Status
- Active
- Expire Date
- April 09, 2025
Manufacturer
- Manufacturer Name
- Beckman Coulter, Inc.
Model information
- Model ID(s)
- B40602
Product accessories
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About this record
Access comprehensive regulatory information for DxH 520 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 ME0000000973SFDAA00014 and manufactured by Beckman Coulter, Inc..
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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