CARDIONOVUM GmbH,

The CFDI officially issued the *Notice of Results of Overseas Remote Inspection on Imported Medical Devices* covering your company's RESTORE DEB Paclitaxel Releasing PTCA Balloon Catheter and APERTO OTW Paclitaxel Releasing Hemodialysis Shunt Balloon Dilatation Catheter products on July 3, 2026, with a copy furnished to your registration agent, Cardionovum Medical Device (Wuhan) 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
July 8,2026