Singapore HSA registration DE0507611
OMRON Automatic Upper Arm Blood Pressure Monitor + ECG
Singapore·CLASS B·OMRON HEALTHCARE Co., Ltd·Registered December 15, 2022Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0507611
- Registration Date
- December 15, 2022
- Change Notification Approval Date
- March 30, 2023
- Retention Due Date
- December 14, 2025
Product description
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
- Short Name
- OMRON HEALTHCARE Co., Ltd
- Address
- 53, Kunotsubo, Terado-cho, Muko, Kyoto, 617-0002, JAPAN
Registrant
- Address
- 438B ALEXANDRA ROAD, ALEXANDRA TECHNOPARK, #08-01/02, SINGAPORE 119968
Importer
- Address
- 438B ALEXANDRA ROAD, ALEXANDRA TECHNOPARK, #08-01/02, SINGAPORE 119968
Model information
- Model Name(s)
- OMRON Automatic Upper Arm Blood Pressure Monitor + ECG Small Cuff Wide Range Soft Cuff OMRON connect App
- Model Identifier(s)
- Complete (HEM-7530T) HEM-CS24 Type B HEM-RML31 Type B OMRON connect
About this record
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.
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