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Dongguan Kaiyi Technology Co., Ltd.
Contact number: 18157981781

Kaiyi Technology Obtained Medical Device Production License

According to the relevant provisions of the medical device classification catalog, medical masks used for epidemic prevention belong to my country's second-level medical devices. According to the "Regulations on the Supervision and Administration of Medical Devices" promulgated by the State Council, manufacturers engaged in the production of Class II medical devices must obtain medical device production licenses and registration certificates. In other words, if the second type of medical device is not recorded in accordance with the regulations, it is illegal to sell medical masks in Moments, which may result in administrative penalties. If the situation is serious, you may even be punished.

As a medical device manufacturer for epidemic prevention and control, Kaiyi Technology not only fully implements the main responsibility of the enterprise, but also strengthens the sense of responsibility and further enhances the consciousness of responsibility implementation; continuously strengthens system management to ensure continuous compliance of the quality management system; strengthens risk management , And deal with the quality risks found in a timely manner.

Kaiyi Technology is equipped with corresponding production machinery and experimental equipment; it has professional production technology and a complete quality system. The main production and operation of the second-class medical equipment, disposable medical masks, disposable flat masks, disposable children's masks, KN95 masks are the varieties produced all year round. Obtained a medical device production license in April 2021. In 2021, we will continue to apply for medical device registration certificates for medical protective masks, medical surgical masks, and medical protective clothing. We continue to improve product technology; break through traditional and regional concepts, enhance development and innovation awareness, develop more, newer and better medical products to meet customer needs.

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