Breaking: Xinyan Medical Receives NMPA and FDA Dual Certification

👏 Warm congratulations to Xinyan Medical! The full-lead wearable dynamic ECG recorder series has been awarded both NMPA and FDA certification, securing market access from two authoritative regulatory agencies. 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 at a Glance:

• 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

With China's authoritative regulation on one side and the global "gold standard" for medical devices on the other, dual certification means the full-lead wearable dynamic ECG recorder series meets international high standards in safety, effectiveness and quality management.

02 Behind the Dual Certification: Substantial Value

The full-lead wearable dynamic ECG recorder series has successfully obtained both NMPA and FDA 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 earned 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 market in Xinyan Medical's overseas strategy. This FDA approval opens the U.S. market for the YMHeart series and marks a key step in Xinyan Medical's globalization strategy. Going forward, Xinyan Medical will accelerate market access in Europe, Southeast Asia, the Middle East and other regions, build a global marketing and service network, and bring China-made ECG monitoring products to more medical institutions and patients around the world.

04 Tribute to the Team, Going International

Behind these achievements are the hard work and persistence of every member of the Xinyan team. Our respect goes to this dedicated team! May Xinyan Medical's business continue to prosper, and may domestic medical devices go global and shine worldwide!