Gangan Medical has successfully obtained approval for the pre-market notification of Injection Pen Needle
Gangan Medical Technology Jiangsu Co., Ltd. (hereinafter referred to as "Gangan Medical") has successfully obtained approval from the US Food and Drug Administration (hereinafter referred to as "FDA") for its Injection Pen Needle - Xiulin Needle ® Application approval for pre-market registration notification (510k code: K192464).
This product obtained the medical device registration certificate approved by the China National Medical Products Administration in September 2019. At the same time, Gangan Medical also submitted a pre-market notification (510k) application to the US FDA for medical devices. After FDA review, the substantial equivalence of the product has been confirmed and approval has been obtained to sell the device in accordance with general control regulations. Subsequently, the company will also apply to the FDA for registration of its business location and product listing. After approval, Xiulin Needle ® Can be sold in the US market.
Image: FDA Approval Document for Gan Gan Medical Injection Pen Needles
There are five specifications of injection pen needles approved this time, according to the ISO 11608-2:2012 standard, with diverse models and flexible installation, which can be adapted to most mainstream pen insulin syringes on the market.
About Gangan Medical
Gangan Medical Technology Jiangsu Co., Ltd. is a high-end medical device production base that integrates high technology, innovation, and specialization. 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 research and development of insulin injection products.
References
1.PRNewswire.(2020,Oct24）Pen NeedlesMarket To Reach USD 1.18 Billion By 2026|Reports And Data[Press release].Retrieved from https://www.prnewswire.com/news-releases/pen-needles-market-to-reach-usd-1-18-billion-by-2026--reports-and-data-300944803.html