Lutonix, Inc.,

The CFDI officially issued the *Notice of Results of Overseas Remote Inspection on Imported Medical Devices* covering your company's LUTONIX™ 035 Drug Coated Balloon PTA Catheter Products on August 25,2026,with a copy furnished to your registration agent,Bard Healthcare Science (Shanghai) Co.,Ltd. Please check and confirm receipt thereof.

Should you have any inquiries, please contact us promptly.

Contact: Qin Shaoyan

Tel.+86 10 68441776

Center for Food and Drug Inspection of NMPA
August 26, 2026