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Singapore HSA registration DE0507804

Shanghai Kohden Cardiofax M Electrocardiograph ECG-3350

Singapore flagSingapore·CLASS B·Shanghai Kohden Medical Electronic Instrument Corporation·Registered February 20, 2023
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0507804
Registration Date
February 20, 2023
Change Notification Approval Date
March 11, 2025
Retention Due Date
February 19, 2026
Product description
The Shanghai Kohden ECG-3350 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 device is a portable ECG acquisition terminal which measures up to 12-lead ECG waveforms. The intended use is only for diagnosis, not for monitoring of vital physiological parameters. ECG-3350 is intended to be used by qualified medical personnel within a medical facility, such as hospital or clinic and neonates, children and adults can be diagnosed with this electrocardiograph.
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
Model Identifier(s)
ECG-3350
About this record

Access comprehensive regulatory information for Shanghai Kohden Cardiofax M Electrocardiograph ECG-3350 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507804 and owned by Shanghai Kohden Medical Electronic Instrument Corporation. The device was registered on February 20, 2023.

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