Breaking: Xinyan Medical Receives NMPA and FDA Dual Certification, the Only One Globally!

👏 Warm congratulations to Xinyan Medical! The full-lead wearable dynamic ECG recorder series has received both NMPA and FDA certifications, achieving the remarkable distinction of being the only one globally with dual authoritative certification. This is a milestone for Xinyan Medical and a highlight moment for domestic medical devices going international.

01 Dual Certification, Double Authoritative Endorsement

NMPA Certification: Authoritative recognition by China's National Medical Products Administration.

FDA Certification: U.S. FDA 510(k) substantial equivalence determination, K254119, officially approved on September 11, 2026.

Certification Quick View:

• 510(k) Number: K254119
• Device Name: Wearable ECG Recorder
• Approved Models: YMHeart XY-12 / XY-1201 / XY-1202 / XY-1203 / XY-03 / XY-0301 / XY-0302 / XY-0303
• Approval Date: September 11, 2026

On one side is China's authoritative regulation, on the other is the global "gold standard" for medical devices. Dual certification means that Xinyan Medical's full-lead wearable dynamic ECG recorder series meets international high standards in safety, effectiveness, and quality system.

02 The Only One Globally, Highly Valuable

The full-lead wearable dynamic ECG recorder series has achieved the remarkable distinction of being the only one globally with dual authoritative certification. This is not a simple registration approval, but the inevitable result of long-term R&D investment, technical accumulation, and quality commitment. From China to the U.S., from NMPA to FDA, Xinyan Medical has won global authoritative recognition with its strength.

03 Global Layout, One Step Further

The United States is one of the largest medical device markets in the world and a core position in Xinyan Medical's overseas strategy. This FDA approval opens the U.S. market channel for the YMHeart series and is a key move in Xinyan Medical's globalization strategy. In the future, Xinyan Medical will accelerate market access in Europe, Southeast Asia, the Middle East, and other global markets, build a global marketing and service network, and let China-made ECG monitoring products serve medical institutions and patients in more countries and regions.

04 Tribute to the Team, Going International

Behind the achievements are the hard work and persistence of every Xinyan person. Tribute to the striving team! Wishing Xinyan Medical's business prosperity! Wishing domestic medical devices go international and shine globally!