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Singapore HSA registration DE0508186

Norav Medical NORAV High Resolution Recorders

Singapore flagSingapore·CLASS B·Norav Medical Ltd.·Registered June 12, 2023
Device classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0508186
Registration Date
June 12, 2023
Retention Due Date
June 11, 2025
Product description
The NR recorder is used for acquiring, recording (to SD card), transmitting (via BT), analyzing (using software), displaying and printing (using software) ECG’s. Intended for patients requiring: Ambulatory (Holter) recording, Use within the physician office setting by the medical professional: Resting ECG, Stress ECG, Telemetry ECG. Such device is most frequently used for the indications below: Evaluation of symptoms suggesting arrhythmia or myocardial ischemia, Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients, Evaluation of patients for ST segment changes, Evaluation of a patient's response after resuming occupational or recreational activities (For example, after myocardial infarction or cardiac surgery), Evaluation of patients with pacemakers, Reporting of QT interval.
Product Owner
Name
Norav Medical Ltd.
Short Name
Norav Medical Ltd.
Address
4 Hamada St., Yokneam Illit 2069202, ISRAEL
Registrant
Name
EO MEDICAL PTE. LTD.
Address
29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #04-23, SINGAPORE 138565
Importer
Name
EO MEDICAL PTE. LTD.
Address
29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #04-23, SINGAPORE 138565
Model information
Model Name(s)
NR Recorder Kit IEC NR Recorder Kit IEC Norav Mobile ECG Norav Mobile ECG PC-ECG 1200
Model Identifier(s)
NR-1207-3 NR-1207-E Norav Mobile ECG (Android) Norav Mobile ECG (iOS) PC-ECG 1200
About this record

Access comprehensive regulatory information for Norav Medical NORAV High Resolution Recorders in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508186 and owned by Norav Medical Ltd.. The device was registered on June 12, 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