Singapore HSA registration DE0510012
Shenzhen Mindray Bio-Medical Electronics Mindray Auto Hematology Analyzer
Singapore·CLASS B IVD·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·Registered November 06, 2024Device 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 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.
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 2×3ml BC-RET Hematology Control BC-RET Hematology Control BC-RET Hematology Control SC-CAL PLUS 1×3 ml DS Diluent DS Diluent M-6 DR DILUENT 4L×1 M-6 DR DILUENT 1L×4 M-6LD LYSE 4L×1 M-6LD LYSE 1L×4 M-6 LN Lyse 4L×1 M-6 LN Lyse 1L×4 M-6 LH Lyse 4L×1 M-6 LH Lyse 1L×4 M-6 FN Dye 48mL×1 M-6 FN Dye 12mL×4 M-6 FR Dye 48mL×1 M-6 FR Dye 12mL×4 M-6 FD Dye 48mL×1 M-6 FD Dye 12mL×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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD