Recently, the State Food and Drug Administration issued the circular on the results of the national supervision and sampling of medical devices (No. 1) (No. 22 in 2022). In order to strengthen the supervision and management of medical devices and ensure the quality, safety and effectiveness of medical devices, the State Drug Administration organized the product quality supervision and sampling inspection of five varieties such as intervertebral fusion cage and semiconductor laser treatment machine. A total of 12 batches (sets) of products did not meet the standards.
Among them, one set of handheld ultrasonic diagnostic equipment is produced by Weihai Weigao Medical Imaging Technology Co., Ltd., and the external marks of the equipment or equipment components do not meet the standards.
The full digital handheld ultrasonic diagnostic instrument marked that the registrant and agent are Weihai Weigao Medical Imaging Technology Co., Ltd. the items that do not meet the standard are the external marks of the equipment or equipment parts, the specification and model is mu-1, and the production date / batch number / factory number is March 2021 / us0401210001 The sampling unit is Shandong Provincial Drug Administration, and the inspection unit is Beijing medical device inspection and Research Institute.
7 operation shadowless lamps: produced by Changzhou Meiya medical Lighting Co., Ltd., Hebei Yi’an Allmed Medical Products Co.Ltd(002950) Equipment Co., Ltd., Hengzhi medical equipment (Shanghai) Co., Ltd., Shandong KANGYI medical device Co., Ltd., Shandong xinyuchen medical device group Co., Ltd. Shinva Medical Instrument Co.Ltd(600587) , Shanghai Jishun medical device manufacturing Co., Ltd., involving protective grounding impedance, central illumination, single shutter illumination measurement The total irradiance does not meet the standard.
For the surgical shadowless lamp with the registrant and agent of Shinva Medical Instrument Co.Ltd(600587) (hereinafter referred to as ” Shinva Medical Instrument Co.Ltd(600587) “, Shinva Medical Instrument Co.Ltd(600587) . SH), the items that do not meet the standard are central illumination and total irradiance, the specification and model are smart r40plus, and the production date / batch number / factory number is 20210401 / 21041401001 The sampling unit is Shandong drug administration, and the inspection unit is Zhejiang medical device inspection and Research Institute.
The largest shareholder of Weihai Weigao Medical Imaging Technology Co., Ltd. is Weihai Weigao Medical System Co., Ltd., with a shareholding ratio of 95.00%. Weihai Weigao Medical System Co., Ltd. is a wholly-owned subsidiary of Weihai Weigao International Medical Investment Holding Co., Ltd.
Shandong Weigao Orthopaedic Device Co.Ltd(688161) (hereinafter referred to as ” Shandong Weigao Orthopaedic Device Co.Ltd(688161) “, Shandong Weigao Orthopaedic Device Co.Ltd(688161) . SH) annual report shows that Weihai Weigao Medical System Co., Ltd. is its group brother company. Weigao Co., Ltd. is the controlling shareholder of Shandong Weigao Orthopaedic Device Co.Ltd(688161) , Weigao group is the controlling shareholder of Weigao Co., Ltd., and Weihai Weigao International Medical Investment Holding Co., Ltd. is the controlling shareholder of Weigao group.
Shinva Medical Instrument Co.Ltd(600587) official website shows that Shinva Medical Instrument Co.Ltd(600587) was founded in 1943 and listed on the Shanghai Stock Exchange ( Shinva Medical Instrument Co.Ltd(600587) ) in September 2002. It is a leading Chinese health industry group integrating scientific research, production, sales, medical services and trade logistics of medical devices and pharmaceutical equipment, ranking 47th in the list of top 100 global medical device companies in 2018.
