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ISO13485
Shanghai Wonzigene Biological obtained ISO13485 certification

In September 2023, Shanghai Wonzigene Biotechnology Co., Ltd. passed the strict audit of SGS experts and successfully obtained the ISO13485:2016 “Medical Device Quality Management System” certification. This important milestone marks a significant breakthrough in our development process!

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Wonzigene Biological new
products approved to market!

Recently, the “carcinoembryonic antigen, neuron specific enolase, Cytokeratin 19 Fragment Detection Kit (Flow fluorescence luminescence)” (referred to as “TM3”) independently developed by Shanghai Wonzigene Biotechnology Co., Ltd. has been approved by Shanghai Municipal Drug Administration to go on the market!

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Shanghai Wonzigene Biological has recently obtained the Medical Device Registration Certificate and the Medical Device Production License.

Zhejiang Oriental Gene Biological PRODUCTS Co., LTD
Shanghai Wonzigene Biological Technology Co., LTD. (” Shanghai Wonzigene Biological “), a wholly-owned subsidiary, has recently obtained the “Medical Device Registration Certificate” and “Medical Device Production License” approved by the Shanghai Municipal Drug Administration. At present, Shanghai Wonzigene Biological has the conditions for production.

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