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Shenzhen Mindray Bio-Medical Electronics Mindray Auto Hematology Analyzer - HSA Registration DE0510012

Access comprehensive regulatory information for Shenzhen Mindray Bio-Medical Electronics Mindray Auto Hematology Analyzer in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0510012 and owned by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The device was registered on November 06, 2024.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B IVD
DE0510012
Shenzhen Mindray Bio-Medical Electronics Mindray Auto Hematology Analyzer
HSA Registration Number: DE0510012
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Product Description

The Auto Hematology Analyzer is a quantitative, automated hematology analyzer for In Vitro Diagnostic Use in clinical laboratories; it provides Complete Blood Count, Leukocyte 5-part Differential, Hemoglobin Concentration Measurement, Reticulocyte and Nucleated Red Blood Cell Measurement, and Erythrocyte Sedimentation Rate (ESR) Measurement for blood samples, as well as Body Fluid analysis. ESR can be used as aids to diagnosis of inflammation diseases. The subtypes of body fluid supported by BC-6800Plus include cerebrospinal fluid, serous cavity fluid (pleural fluid and ascitic fluid) and synovial fluid.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Hematology
Registration Information
Registration Number
DE0510012
Registration Date
November 06, 2024
Retention Due Date
November 05, 2025
Product Owner
Short Name
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Address
Mindray Building,, Keji 12 Road South, High-Tech Industrial Park, Nanshan, Shenzhen 518057, CHINA
Registrant
Address
18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966
Importer
Address
18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966
Model Information
Model Name(s)
BC-6D Hematology Control BC-6D Hematology Control BC-6D Hematology Control BC-6D Hematology Control BC-RET Hematology Control BC-RET Hematology Control BC-RET Hematology Control BC-RET Hematology Control BC-6D Hematology Control BC-RET Hematology Control SC-CAL PLUS 2ร—3ml BC-RET Hematology Control BC-RET Hematology Control BC-RET Hematology Control SC-CAL PLUS 1ร—3 ml DS Diluent DS Diluent M-6 DR DILUENT 4Lร—1 M-6 DR DILUENT 1Lร—4 M-6LD LYSE 4Lร—1 M-6LD LYSE 1Lร—4 M-6 LN Lyse 4Lร—1 M-6 LN Lyse 1Lร—4 M-6 LH Lyse 4Lร—1 M-6 LH Lyse 1Lร—4 M-6 FN Dye 48mLร—1 M-6 FN Dye 12mLร—4 M-6 FR Dye 48mLร—1 M-6 FR Dye 12mLร—4 M-6 FD Dye 48mLร—1 M-6 FD Dye 12mLร—4 BC-BF Hematology Control BC-BF Hematology Control BC-BF Hematology Control BC-BF Hematology Control BC-BF Hematology Control BC-BF Hematology Control BC-BF Hematology Control BC-BF Hematology Control ESR Solution Reagent ESR Solution Reagent Probe Cleanser Probe Cleanser Mindray Auto Hematology Analyzer BC-6800 Plus Sample Processing System
Model Identifier(s)
105-002421-00 105-002422-00 105-002423-00 105-002424-00 105-002429-00 105-002430-00 105-002431-00 105-002432-00 105-003219-00 105-003221-00 105-003223-00 105-004088-00 105-004089-00 105-004090-00 105-004091-00 105-012283-00 105-012284-00 105-012285-00 105-012286-00 105-012287-00 105-012288-00 105-012289-00 105-012290-00 105-012291-00 105-012292-00 105-012293-00 105-012294-00 105-012295-00 105-012296-00 105-012297-00 105-012298-00 105-018564-00 105-018567-00 105-018572-00 105-018573-00 105-018582-00 105-018586-00 105-018587-00 105-018588-00 105-026688-00 105-026689-00 105-041321-00 105-041322-00 BC-6800 Plus CAL 8000