Gangan Medical Technology Jiangsu Co., Ltd. (hereinafter referred to as "Gangan Medical") has successfully obtained approval from the US Food and Drug Administration (FDA) for its Injection Pen Needle - Xiulin Needle ® Application approval for pre registration and listing notification (510k code: K192464).
This product obtained the medical device registration certificate approved by the National Medical Products Administration of China in September 2019. At the same time, Gangan Medical also submitted a pre market notification (510k) application for medical devices to the US FDA. After FDA review, the substantial equivalence of the product has been confirmed and approval has been obtained for the sale of the device in accordance with general control regulations. In the future, the company will also apply to the FDA for registration of its business location and product listing. After approval, Xiulin needle will be used ® Can be sold in the US market.
Image: FDA approval documents for Gan Gan Medical Injection Pen needles
There are a total of five specifications of injection pen needles approved this time, according to the ISO 11608-2:2012 standard, with a variety of models and flexible installation, which can be adapted to most mainstream pen insulin syringes on the market.
About Gan Gan Medical
Gangan Medical Technology Jiangsu Co., Ltd. is a high-end medical device production base that integrates high technology, innovation, and specialization in Ganli. Gangan Medical has a building area of 12000 square meters and a total production area of 4500 square meters. It is mainly responsible for the production of medical devices, blood glucose monitoring for next-generation cloud data management, and the research and development of insulin injection products.
