Single-use hydrophilic-coated silicone catheterization kit - NMPA Registration 粤械注准20232142164
Access comprehensive regulatory information for Single-use hydrophilic-coated silicone catheterization kit in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 粤械注准20232142164 and owned by Well Lead Medical Co., Ltd.. The device was approved on December 21, 2023.
This page provides complete registration details including registrant information, province location (Guangdong), 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 used to export urine from the patient's bladder through the urethra to the outside of the body and into the urine collection container.
用于将病人膀胱中的尿液经尿道向体外导出并导入到集尿容器中。
It is composed of a hydrophilic coated silicone urinary catheter, a sterile water pack, a cloth, an iodophor bag, gauze, pointed tweezers, examination gloves, a curved plate, a tray, a round-tipped tweezers, a drainage bag, a water injector, a hole towel, a medical paper tape, a catheter clamp, and a urethral catheter fixation sticker. Among them, hydrophilic coated silicone urinary catheter, sterile water pack, cloth towel, and iodophor bag are standard, and the rest of the accessories are optional, and the product is sterilized by ethylene oxide.
由亲水涂层硅胶导尿管、无菌水包、铺巾、碘伏包、纱布、尖头镊子、检查手套、弯盘、托盘、圆头镊子、引流袋、注水器、洞巾、医用纸质胶带、导管夹、尿管固定贴组成。其中亲水涂层硅胶导尿管、无菌水包、铺巾、碘伏包为标配，其余配件为选配，产品经环氧乙烷灭菌。