Saudi Arabia SFDA registration ME0000000973SFDAA00005
DxH 500
Saudi Arabia·Chemicals·Beckman Coulter, Inc.·General IVD(Others)ActiveProduct information
Automated Hematology Analyzer
Product use
The DxH 500 identifies and enumerates the parameters: WBC, RBC, Hgb, Hct,
MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, LY%, LY#, MO%, MO#, NE%, NE#, EO%, EO#,
BA%, BA# in whole-blood samples (venous and capillary) collected in K2EDTA and K3EDTA
anticoagulants, and prediluted whole blood.
Device classification
- Risk Class
- General IVD(Others)
- Product Category
- Chemicals
- Product Type
- IVD
Registration information
- Registration ID
- ME0000000973SFDAA00005
- Authorization ID
- MDMA-1-2019-0911
- Status
- Active
- Expire Date
- April 09, 2025
Manufacturer
- Manufacturer Name
- Beckman Coulter, Inc.
Model information
- Model ID(s)
- B40601
Product accessories
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About this record
Access comprehensive regulatory information for DxH 500 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 ME0000000973SFDAA00005 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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