Health

National Medical Products Administration: Cancellation of registration certificates for 17 medical devices including Eustachian tube pressure measuring instruments

2025-07-10   

On July 9th, the National Medical Products Administration issued a notice on the cancellation of 17 medical device registration certificates, including the Eustachian tube pressure measuring instrument. The full text is as follows: Announcement of the National Medical Products Administration on the cancellation of 17 medical device registration certificates, including the Eustachian tube pressure measuring instrument (No. 66 of 2025) According to the provisions of the "Regulations on the Supervision and Administration of Medical Devices", based on the application of enterprises, the National Medical Products Administration now cancels the medical device registration certificates of the following 11 enterprises for a total of 17 products: 1. One product of French technology company LADIFUSION TECHNOLOGY FRANCAISE: Eustachian tube pressure measuring instrument Device for diagnosis of Eustachian tube pathologies, registration certificate number: National Medical Device Injection 2016 2072333. 2、 One product from Fujifilm Medical Health Co., Ltd.: Brain Function Quantitative Imaging Device, registration certificate number; National equipment injection 20202070183. 3、 One product of Shanghai Anhan Medical Technology Co., Ltd.: Capsule Endoscope System, registration certificate number: National Medical Device Approval 20173061370. 4、 One product of Guangzhou Haozhi Biotechnology Co., Ltd.: Human CYP2C9 and VKORC1 gene polymorphism detection kit (fluorescence PCR melting curve method), registration certificate number: National Medical Device Approval 20173403220. 5、 Six products from Japan's Lai Fu En Co., Ltd.: Adjustable Bend Electrophysiological Catheters and Accessories, Registration Certificate Number: National Medical Products Administration 20163070791; Fixed curved electrophysiological catheter and accessories, registration certificate number: National Medical Device Registration No. 20163070790; Circular electrophysiological catheter and accessories, registration certificate number: Guoxie Zhujin 20163070792; Multi pole catheter for intracardiac defibrillation, registration certificate number: Guoxie Zhujin 20163072451; Intracardiac defibrillator, registration certificate number: Guoxie Zhujin 20163082366; Radiofrequency ablation catheter, registration certificate number: Guoxie Zhujin 20183011581. 6、 One product of Yeju Medical Equipment (Shenzhen) Co., Ltd.: Intracranial Balloon Dilation Catheter, registration certificate number: National Medical Device Approval 20233030156. 7、 One product from Shizong Medical Equipment Co., Ltd.: Disposable endoscope specimen retrieval bag, registration certificate number: National Medical Device Registration No. 20242060086. 8、 One product from Jiangxi Qingshantang Medical Equipment Co., Ltd.: Disposable infusion set with needle, registration certificate number: National Medical Device Approval 20173140098. 9、 One product of Hunan Sanrui Biotechnology Co., Ltd.: disposable infusion disinfection connector, registration certificate number: National Medical Device Approval 20203140287. 10、 DreamCon Co., Ltd. has one product, Soft Contact Lens, registered with National Medical Products Administration No. 20153161670. 11、 Boule Medical AB's two products: BOULE CAL, a calibration product for blood analyzers used by Boule Medical Equipment Co., Ltd., with registration certificate number: Guoxie Zhujin 20172400647; The quality control product BOULE CON-DIFF is used for blood analyzers, with registration certificate number: National Medical Device Injection 20172400645. This is to announce. (New Society)

Edit:XINGYU Responsible editor:LIUYANG

Source:cnpharm.com

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