Suzhou Yuyue Medical Technology Co., Ltd. FDA Approvals

0 new drug approvals and 2 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
BreathCare PAP III (YH-390N)510(k)Oct 23, 2026Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Oct 23, 2026
Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow Mask510(k)Jul 2, 2021Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Jul 2, 2021