Biotronik AG,

The CFDI officially issued the *Notice of Results of Overseas Remote Inspection on Imported Medical Devices* covering your company’s Passeo-18 Lux Paclitaxel releasing PTA Balloon Catheter and Peripheral self-expanding Nitinol stent system on July 29, 2026, with a copy furnished to your registration agent, Tailifu Medical Equipment Trading (Shanghai) Co., Ltd. Please check and confirm receipt thereof.

Should you have any inquiries, please contact us promptly.

Contact: Zhang Jing
Tel.+86 10 68441792

Center for Food and Drug Inspection of NMPA
July 29, 2026