OMRON Automatic Upper Arm Blood Pressure Monitor + ECG - HSA Registration DE0507611
Access comprehensive regulatory information for OMRON Automatic Upper Arm Blood Pressure Monitor + ECG in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507611 and owned by OMRON HEALTHCARE Co., Ltd. The device was registered on December 15, 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.
The device is intended to measure blood pressure only, electrocardiogram (ECG) only or blood pressure and ECG simultaneously. The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult population. The device is intended to record, store, and transfer single-channel electrocardiogram (ECG) rhythms. The device in combination with a smartphone, displays ECG rhythms and detects the presence of atrial fibrillation, bradycardia, tachycardia and normal sinus rhythm. The device is intended for use by patients with known or suspected heart conditions, or health-conscious individuals in a general household situation. The device has not been tested and it is not intended for pediatric use.