HSA · registration DE0507611OMRON Automatic Upper Arm Blood Pressure Monitor + ECG
- Registration number
- DE0507611
- Model name
- OMRON Automatic Upper Arm Blood Pressure Monitor + ECG; Small Cuff; Wide Range Soft Cuff; OMRON connect App
- Model identifier
- Complete (HEM-7530T); HEM-CS24 Type B; HEM-RML31 Type B; OMRON connect
- Registration date
- December 15, 2022
- Source update date
- March 30, 2023
- Risk class
- Class B
- Product owner
- OMRON HEALTHCARE Co., Ltd
- Registrant / registration holder
- OMRON HEALTHCARE SINGAPORE PTE LTD
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.
- Product owner address
- 53, Kunotsubo, Terado-cho, Muko, Kyoto, 617-0002, Japan
- Registrant address
- 438B ALEXANDRA ROAD, #08-01/02, ALEXANDRA TECHNOPARK, Singapore 119968
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.