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Singapore HSA registration DE0506086

Shanghai Kohden cardiofaxC Electrocardiograph ECG-3150

Singapore flagSingapore·CLASS B·Shanghai Kohden Medical Electronic Instrument Corporation·Registered August 18, 2021
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0506086
Registration Date
August 18, 2021
Change Notification Approval Date
March 11, 2025
Retention Due Date
August 17, 2025
Product description
The Shanghai Kohden ECG-3150 electrocardiograph is intended for medical use to process the electrical signals produced by the heart, which are acquired through two or more electrodes, and to display waveforms and/or prepare a record of these electrical signals. This instrument is a portable ECG acquisition terminal which measures up to 12 leads ECG waveforms. The intended use is just only for diagnosis, not for monitoring of vital physiological parameters. Main functions are recording patient's resting ECG signal and printing the record.
Product Owner
Name
Shanghai Kohden Medical Electronic Instrument Corporation
Short Name
Shanghai Kohden Medical Electronic Instrument Corporation
Address
No. 567 Huancheng Bei Road, Shanghai Comprehensive Industrial, Development Zone, Fengxian District, Shanghai 201401, CHINA
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)
Electrocardiograph Software kit
Model Identifier(s)
ECG-3150 QS-315E
About this record

Access comprehensive regulatory information for Shanghai Kohden cardiofaxC Electrocardiograph ECG-3150 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506086 and owned by Shanghai Kohden Medical Electronic Instrument Corporation. The device was registered on August 18, 2021.

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