Disposable endoscopic cutting and suturing instrument - NMPA Registration 京械注准20242020061
Access comprehensive regulatory information for Disposable endoscopic cutting and suturing instrument in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 京械注准20242020061 and owned by B.J.Zh.F.Panther Medical Equipment Co., Ltd.. The device was approved on February 08, 2024.
This page provides complete registration details including registrant information, province location (Beijing), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.
It is suitable for gastric, lung tissue and digestive tract surgical anastomosis.
适用于胃、肺组织和消化道手术吻合用。
The disposable laparoscopic cutting stapler consists of a barrel, a rotating head, a safety button, a trigger (movable handle), and an upper and lower shell (fixed handle). No components included. The product is sterilized with ethylene oxide and used once. The product is valid for 5 years. Product raw material information: The material of the barrel is 06Cr19Ni10, and the standard is GB/T1220-2007. The material of the swivel head and the safety button is PC, and the standard is GB/T1220-2007. The material of the trigger (movable handle) is DUPONTPPAHTN51G35HSL, and the standard that meets it is GB/T12672-2009. The material of the upper and lower shell (fixed handle) is PC and TPE, and the standards that meet the standards are GB/T12672-2009 and YY0334-2002.
一次性使用腔镜下切割吻合器由由枪管、旋转头、保险按钮、扳机（活动手柄）、上下壳（固定手柄）组成。不含组件。产品采用环氧乙烷灭菌，一次性使用。产品有效期5年。产品原材料信息：枪管的材料是06Cr19Ni10，符合的标准为GB/T1220-2007。旋转头和保险按钮的材料是PC,符合的标准为GB/T1220-2007。扳机（活动手柄）的材料是DUPONTPPAHTN51G35HSL，符合的标准为GB/T12672-2009。上下壳（固定手柄）的材料是PC、TPE，符合的标准为GB/T12672-2009、YY0334-2002。
5 years
5年