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SNQ Quality Mark
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Product Description

The "AUO Health" Pulse Detecting System simulates the physician's three-finger pulse examination using high-precision, multi-array pressure sensors, converting finger sen­sations into actual pressure values. The collected pulse conditions provides physicians with an objective clinical reference.

Product Features

Advanced Three-Section Multi-Array Sensing enables precise automatic positioning and pulse-taking with highly sensitive multi-point pressure sensors, significantly reducing manual positioning time.

Micron-level height control automatically identifies the optimal measurement depth and maintains consistent pressure to capture high-quality pulse wave signals with maximum amplitude.

Automatic self-check at every startup to ensure system integrity and measurement accuracy, the system delivers fast, precise, and reliable digital pulse measurement for modern Traditional Chinese Medicine and smart healthcare applications.


Approvals

MOHW-MD-No.007456

Product Verification

Product design and development, together with product verification activities, are performed in compliance with the TFDA Quality Management System (QMS) requirements and ISO 13485:2016.


QC Implementation

Quality control during the production process is conducted in accordance with the TFDA Quality Management System (QMS) requirements and ISO 13485:2016.


Risk Management System

To ensure that risks associated with the development of medical devices are systematically identified, evaluated, and addressed, and that comprehensive risk management activities are performed throughout the entire product lifecycle, a Medical Device Risk Management Procedure has been established. Appropriate risk control measures are implemented to comply with applicable regulatory requirements, and a product-specific Risk Management Report is prepared for each individual medical device.


Post-Market Surveillance

Post-market management is conducted in accordance with the TFDA Quality Management System (QMS) requirements and ISO 13485:2016.

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Medical Devices

"AUO Health" Pulse Detecting System

“AUO Health” Pulse Detecting System captures pulse signals and provides digital results for efficient patient record management.
Organization
AUO Health Inc.
Certification Year
2025
"AUO Health" Pulse Detecting System
"AUO Health" Pulse Detecting System
"AUO Health" Pulse Detecting System