Saudi Arabia SFDA registration ME0000001200SFDAA00009
UniCel DxH 800 Coulter Cellular Analysis system
Saudi Arabia·Chemicals·Beckman Coulter, Inc.·General IVD(Others)ActiveProduct information
Hematology Analyzer
Product use
The UniCel DxH 800 analyzer is a quantitative, multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.
The UniCel DxH 800 analyzer identifies and enumerates the parameters.
Device classification
- Risk Class
- General IVD(Others)
- Product Category
- Chemicals
- Product Type
- IVD
Registration information
- Registration ID
- ME0000001200SFDAA00009
- Authorization ID
- GHTF-2019-5609
- Status
- Active
- Expire Date
- May 01, 2022
Manufacturer
- Manufacturer Name
- Beckman Coulter, Inc.
Model information
- Model ID(s)
- 629029 B24802
Product accessories
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About this record
Access comprehensive regulatory information for UniCel DxH 800 Coulter Cellular Analysis system 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 ME0000001200SFDAA00009 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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