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Singapore HSA registration DE0506570

Shenzhen Mindray Bio-Medical Electronics Patient Monitor ePM 10/12/15

Singapore flagSingapore·CLASS C·Shenzhen Mindray Bio-Medical Electronics Co., Ltd·Registered January 12, 2022
Device classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0506570
Registration Date
January 12, 2022
Change Notification Approval Date
January 21, 2022
Retention Due Date
January 11, 2026
Product description
The ePM series patient monitors (10/12/15) are intended to be used for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters including ECG, arrhythmia detection, ST segment analysis, QT/QTc monitoring, and heart rate, respiration, temperature, pulse oxygen saturation, pulse rate, non-invasive blood pressure, invasive blood pressure, cardiac output, carbon dioxide, oxygen, anesthetic gas and bispectral index. The monitor also provides an interpretation of resting 12-lead ECG. This monitor is to be used in healthcare facilities by clinical professionals or under their guidance. It is 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)
7-pin SpO2 cable ECG cable,12-pin, 3/5-lead, defibrillation-proof AHA/IEC 5-lead Leadset, Adt/Ped, AHA, clip long 3-lead, Leadset, Neo, AHA, clip 12-lead Leadset Limb AHA, clip Adult temperature probe Cuff, bladderless (infant) Cuff, bladderless (Child) Cuff, bladderless (Adult) Cuff, bladderless (Large adult) Cuff, bladderless (Adult) Reusable SpO2 sensor, Adt Reusable SpO2 sensor, Adt NIBP hose Mindray Patient Monitor Mindray Patient Monitor Mindray Patient Monitor
Model Identifier(s)
0010-20-42710 0010-30-42719 0010-30-42729 0010-30-42896 0010-30-42902 0011-30-37393 040-000973-00 040-000978-00 040-000983-00 040-000988-00 040-000993-00 512E-30-90390 512F-30-28263 6200-30-09688 ePM 10 ePM 12 ePM 15
About this record

Access comprehensive regulatory information for Shenzhen Mindray Bio-Medical Electronics Patient Monitor ePM 10/12/15 in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0506570 and owned by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. The device was registered on January 12, 2022.

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