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Singapore HSA registration DE0506796

Edan iSE series Electrocardiograph

Singapore flagSingapore·CLASS B·Edan Instruments, Inc·Registered April 13, 2022
Device classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0506796
Registration Date
April 13, 2022
Retention Due Date
April 12, 2026
Product description
The iSE series electrocardiograph is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only. The electrocardiograph is capable of network communications and supports the informatized management of workflows in hospital and healthcare facilities.
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)
Edan Electrocardiograph Edan Electrocardiograph
Model Identifier(s)
iSE 1210 iSE 1810
About this record

Access comprehensive regulatory information for Edan iSE series Electrocardiograph in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506796 and owned by Edan Instruments, Inc. The device was registered on April 13, 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.

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