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Singapore HSA registration DE0508817

Shenzhen Mindray Bio- Medical Electronics Mindray Vital Signs Monitor

Singapore flagSingapore·CLASS C·Shenzhen Mindray Bio-Medical Electronics Co., Ltd·Registered January 05, 2024
Device classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0508817
Registration Date
January 05, 2024
Retention Due Date
January 04, 2026
Product description
The VS9 and VS8 Vital Signs Monitors are intended for monitoring, displaying, reviewing, storing, alarming, and transferring of multiple physiological parameters including Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Respiration Rate (RR), Non-invasive Blood Pressure (NIBP), Carbon Dioxide (CO2). All the parameters can be monitored on single adult, pediatric, and neonatal patients. The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. VS9 and VS8 Vital Signs Monitors are not intended for helicopter transport, hospital ambulance, or home use.
Product Owner
Name
Shenzhen Mindray Bio-Medical Electronics Co., Ltd
Short Name
Shenzhen Mindray Bio-Medical Electronics Co., Ltd
Address
Mindray Building,, Keji 12th Road South,, Hi-Tech Industrial Park, Nanshan,, Shenzhen, Guangdong, 518057, CHINA
Registrant
Name
ITS SCIENCE & MEDICAL PTE LTD
Address
219 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #08-02, SINGAPORE 159556
Importer
Name
ITS SCIENCE & MEDICAL PTE LTD
Address
219 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #08-02, SINGAPORE 159556
Model information
Model Name(s)
Reusable SpO2 Sensor, Adt, Finger-Tip Reusable SpO2 Sensor, Adt, Finger-Clip Reusable SpO2 Sensor, Adt, Finger-Clip Reusable SpO2 Sensor, Pdt, Finger-Tip Reusable SpO2 Sensor, Pdt, Finger-Clip Reusable SpO2 Sensor, Neo/Pdt/Adt, Bandage SpO2 Sensor Wrap (12PCS/Bag) (english) Disposable SpO2 Sensor, Adt, Non-adhesive Disposable SpO2 Sensor, Inf. Non-adhesive Disposable SpO2 Sensor, Neo. Non-adhesive Disposable SpO2 Sensor, Pdt. Non-adhesive Disposable SpO2 Sensor, Adt. Adhesive Disposable SpO2 Sensor, Inf. Adhesive Disposable SpO2 Sensor. Neo/Adt. Adhesive Disposable SpO2 Sensor, Ptd. Adhesive Vital Signs Monitor Vital Signs Monitor
Model Identifier(s)
512E 512F 512FLH 512G 512H 518B 518C 520A 520I 520N 520P 521A 521I 521N 521P VS 8 VS 9
About this record

Access comprehensive regulatory information for Shenzhen Mindray Bio- Medical Electronics Mindray Vital Signs Monitor in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508817 and owned by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. The device was registered on January 05, 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 C