Singapore HSA registration DE0510132
Eko Health CORE 500 Digital Stethoscope
Singapore·CLASS B·Eko Health, Inc.·Registered December 12, 2024Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0510132
- Registration Date
- December 12, 2024
- Retention Due Date
- December 11, 2025
Product description
The CORE 500TM Digital Stethoscope is intended to be used by clinicians or lay users to electronically amplify, filter, and transfer body sounds and three lead electrocardiogram (ECG) waveforms. The CORE 500TM Digital Stethoscope also displays ECG waveforms and heart rate on the display and accompanying mobile application (when prescribed or used under the care of a clinician or by lay users). A lay user is not intended to interpret or take clinical action based on the device output without consulting with a qualified healthcare professional .
Product Owner
- Name
- Eko Health, Inc.
- Short Name
- Eko Health, Inc.
- Address
- 2100 Powell Street, Suite 300, Emeryville, CA 94608, UNITED STATES
Registrant
- Address
- 116 CHANGI ROAD, WIS@CHANGI, #04-05, SINGAPORE 419718
Model information
- Model Name(s)
- CORE 500 Digital Stethoscope (Earpiece) CORE 500 Digital Stethoscope (Earpiece) CORE 500 Digital Stethoscope (Earpiece) CORE 500 Digital Stethoscope (Chestpiece) CORE 500 Digital Stethoscope (Chestpiece) CORE 500 Digital Stethoscope (Chestpiece)
- Model Identifier(s)
- CAC500 CAC500_BLK CAC500_CHP COR500 COR500_Black COR500_CHP
About this record
Access comprehensive regulatory information for Eko Health CORE 500 Digital Stethoscope in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510132 and owned by Eko Health, Inc.. The device was registered on December 12, 2024.
This page provides complete registration details including product owner information, registrant details, 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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