Singapore HSA registration DE0509718

Shenzhen Mindray Automated Digital Cell Morphology Analyzer

Singapore flagSingapore·CLASS B IVD·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·Registered September 03, 2024
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Hematology
Registration information
Registration Number
DE0509718
Registration Date
September 03, 2024
Retention Due Date
September 02, 2025
Product description
MC-80 Automated Digital Cell Morphology Analyzer locates and presents images of blood cells on the peripheral blood smears. It is intended for the presentation, classification and differential count of each WBC cells; characterization of the red blood cell morphology and platelet estimation.
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)
Automated Digital Cell Morphology Analyzer
Model Identifier(s)
MC-80
About this record

Access comprehensive regulatory information for Shenzhen Mindray Automated Digital Cell Morphology 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 DE0509718 and owned by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The device was registered on September 03, 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