NMPA Revokes 16 Device Registrations across 9 Firms

On August 14, 2026, the National Medical Products Administration released Announcement No. 74 of 2026, canceling the medical device registration certificates of 16 products from 9 companies, based on enterprise applications and in accordance with the "Regulations on the Supervision and Administration of Medical Devices":

LeadM Corporation: Trephine for medical use (Registration No. GJZJ 20172010095); Datascope Corp.: Intra-Aortic Balloon Pump (GJZJ 20193082223); Changchun Biosino Biotechnology Co., Ltd.: Toxoplasma IgG Antibody Detection Kit (Microcolumn Gel Method) (GJZZ 20223400122); Wuxi BioTeke Biotechnology Co., Ltd.: Real-time Fluorescent PCR Analyzer (GJZZ 20223220629); Polymer Technology Systems, Inc.: PTS PANELS HDL Cholesterol Test Strips (Dry Chemistry Method) (GJZJ 20172400508); Hologic (Shanghai) Medical Equipment Co., Ltd.: Ultrasound Diagnostic System (GJZZ 20243061937).

MEDICAL & BIOLOGICAL LABORATORIES CO., LTD. (3 products): MESACUP BP180 TEST (GJZJ 20172406586), FLUORO HEPANA TEST (GJZJ 20172400998), FLUORO AID-1 TEST (GJZJ 20172400991).

NeuWave Medical, Inc. (2 products): NeuWave Certus Microwave Ablation System (GJZJ 20203010011) and NeuWave Certus Ablation Probes (GJZJ 20203010010).

KARL STORZ SE & Co. KG (5 products): Flexible Intubation Videoscope (GJZJ 20152060958), The Mobile Compact Solution (GJZJ 20162064525), Motor System for Endoscope (GJZJ 20162185165), Irrigation and Suction Systems for Endoscope (GJZJ 20212060381), Endovision Camera System (GJZJ 20172061929).

All cancellations were initiated by the respective companies and take effect from the date of this announcement.