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Singapore HSA registration DE0509983

Edan iM3 Vital Signs Monitor

Singapore flagSingapore·CLASS C·Edan Instruments, Inc.·Registered October 28, 2024
Device classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0509983
Registration Date
October 28, 2024
Retention Due Date
October 27, 2025
Product description
The monitor is intended to be used for monitoring, storing, recording, and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitor is intended for use by trained healthcare professionals in hospital environments. Monitored parameters include: NIBP, SpO2, pulse rate, Quick TEMP/Infrared TEMP. The monitor is not intended for MRI environments. Quick TEMP/Infrared TEMP is not intended for neonates.
Product Owner
Name
Edan Instruments, Inc.
Short Name
Edan Instruments, Inc.
Address
#15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District, 518122 , Shenzhen, CHINA
Registrant
Name
MEDICARE (S) PTE LTD
Address
38 JALAN PEMIMPIN, M38, #07-06, SINGAPORE 577178
Importer
Name
MEDICARE (S) PTE LTD
Address
38 JALAN PEMIMPIN, M38, #07-06, SINGAPORE 577178
Model information
Model Name(s)
Filac 3000 Oral Isolation Chamber Filac 3000 Rectal Isolation Chamber NIBP Cuff NIBP Cuff NIBP Cuff NIBP Cuff NIBP Cuff NIBP Cuff NIBP Cuff NIBP Cuff NIBP Cuff SpO2 Sensor (Single Patient use) SpO2 Sensor (Single Patient use) SpO2 Sensor (Single Patient use) SpO2 Sensor (Single Patient use) Filac 3000 Oral Probe 4ft Filac 3000 Thermometer Probe Filac 3000 Thermometer Probe Filac 3000 Thermometer Probe NIBP Cuff NIBP Cuff NIBP Cuff NIBP Cuff NIBP Cuff NIBP Cuff NIBP Cuff NIBP Cuff NIBP Cuff NIBP Cuff NIBP Cuff SpO2 Sensor (Single Patient use) SpO2 Sensor (Single Patient use) SpO2 Sensor (Single Patient use) SpO2 Sensor (Single Patient use) Temperature probe SpO2 Sensor SpO2 Sensor SpO2 Sensor SpO2 Sensor SpO2 Sensor Reusable Blood Pressure Cuff Vital Signs Monitor
Model Identifier(s)
01.22.066159 01.22.066160 01.57.000974 01.57.000976 01.57.000977 01.57.000978 01.57.471157 01.57.471158 01.57.471159 01.57.471160 01.57.471161 01.57.471235 01.57.471236 01.57.471237 01.57.471238 01.57.471312 01.57.471313 01.57.471314 01.57.471315 01.57.471323 01.57.471324 01.57.471326 01.57.471327 01.57.471328 01.57.471329 01.57.471331 01.57.471494 01.57.471495 01.57.471496 01.57.471497 01.57.471746 01.57.471747 01.57.471748 01.57.471749 02.01.110131 02.01.210120 02.01.210121 02.01.210122 02.01.210673 02.57.225000 ADULT E9 iM3
About this record

Access comprehensive regulatory information for Edan iM3 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 DE0509983 and owned by Edan Instruments, Inc.. The device was registered on October 28, 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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