Five batches of medical device registration certificates from three companies including Wuhan Huada Gene were cancelled

The reporter was informed by the State Food and Drug Administration that in accordance with the "Administrative Measures for the Registration of Medical Devices" and the "Regulations on the Registration of In Vitro Diagnostic Reagents", according to the application of the enterprise, the following five companies, including Wuhan Huada Gene Biomedical Engineering Co., Ltd., are now cancelled. Medical device registration certificate for the product.

Including: Wuhan Huada Gene Biomedical Engineering Co., Ltd. 2 products: gene sequencer , registration number: National Food and Drug Administration (quasi) word 2014 No. 3401127; gene sequencer, registration number: national food Supervisor (quasi) word 2014 No. 3401126.

Two products of Huada Gene Biotechnology (Shenzhen) Co., Ltd.: Detection kit for fetal chromosome aneuploidy (T21, T18, T13) (combined probe anchoring ligation sequencing method), registration number: National Food and Drug Administration Machinery (quasi) word 2014 No. 3401129; fetal chromosome aneuploidy (T21, T18, T13) detection kit (semiconductor sequencing method), registration number: National Food and Drug Administration (quasi) word 2014 No. 3401128.

One product of Minimally Invasive Medical Technology (Shanghai) Co., Ltd.: Remote Protector, Registration No.: National Food and Drug Administration (quasi) word 2014 No. 3771704. (Economic Daily)

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