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Singapore HSA registration DE0504963

Nihon Kohden cardiolifeEMS Defibrillator

Singapore flagSingapore·CLASS C·Nihon Kohden Corporation·Registered September 23, 2020
Device classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0504963
Registration Date
September 23, 2020
Retention Due Date
September 22, 2025
Product description
This device is a defibrillator that ends ventricular fibrillation or ventricular tachycardia by delivering a short-duration high-current electrical shock to the heart. This defibrillator can measure ECG and perform asynchronous defibrillation as well as synchronized cardioversion to treat atrial flutter. The defibrillator also has a transcutaneous pacing function so it can be used to treat temporary bradycardia. The defibrillator has a monitoring function to help determine the patient condition before and after defibrillation. In addition to ECG measurement, the defibrillator can monitor non-invasive blood pressure (NIBP), saturated oxygen from a pulse oximeter (SpO2), and body temperature. The defibrillator includes multi-parameter functionality so that fraction of expired CO2, invasive blood pressure (IBP) and cardiac output (esCCO) can be measured by connecting a CO2 sensor kit and blood pressure transducer.
Product Owner
Name
Nihon Kohden Corporation
Short Name
Nihon Kohden
Address
1-31-4 Nishiochiai,, Shinjuku-ku, Tokyo 161-8560, JAPAN
Registrant
Name
Nihon Kohden Singapore Pte Ltd
Address
1 MARITIME SQUARE, HARBOURFRONT CENTRE, #10-34, SINGAPORE 099253
Importer
Name
NIHON KOHDEN SINGAPORE PTE LTD
Address
1 MARITIME SQUARE, HARBOURFRONT CENTRE, #10-34, SINGAPORE 099253
Model information
Model Name(s)
Cardiolife EMS Defibrillator EMS-1052 CO2 adapter, JG-900P CO2 adapter, JG-920P QS-013V CO2 sensor, TG-101T CO2 sensor, TG-121T CO2 sensor kit, TG-900P CO2 sensor kit, TG-920P CO2 Sensor Kit SpO2 PROBE SpO2 PROBE SpO2 PROBE SpO2 PROBE FINGER PROBE Multi-site Probe Multi-site Y Probe SpO2 Probe SpO2 Probe SpO2 Probe SpO2 Probe SpO2 Probe SpO2 Probe SpO2 Probe SpO2 Probe Finger Probe Finger Probe Finger Probe Finger Probe
Model Identifier(s)
EMS-1052 JG-900P JG-920P QS-013V TG-101T TG-121T TG-900P TG-920P TG-980P TL-051S TL-052S TL-061S TL-062S TL-201T TL-220T TL-260T TL-271T TL-271T3 TL-272T TL-272T3 TL-273T TL-273T3 TL-274T TL-274T3 TL-630T1 TL-630T3 TL-631T1 TL-631T3
About this record

Access comprehensive regulatory information for Nihon Kohden cardiolifeEMS Defibrillator in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0504963 and owned by Nihon Kohden Corporation. The device was registered on September 23, 2020.

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