Disposable sterile urinary catheters - NMPA Registration 国械注准20243141963
Access comprehensive regulatory information for Disposable sterile urinary catheters in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20243141963 and owned by Well Lead Medical Co., Ltd.. The device was approved on September 30, 2024.
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 for bladder urination or bladder urination and irrigation after surgery, and the cumulative use time is not more than 30 days.
用于患者膀胱排尿或者手术后患者膀胱排尿和冲洗，累计使用时间不超过30天。
The product consists of a tube body (with fittings), a check valve, a balloon, a coating, a catheter plug (optional), and a guidewire (optional). Among them, the tube body (with joints) and balloon are made of latex, and the coating includes alloy coating and hydrophilic coating, the alloy coating is made of gold, silver and palladium alloy, and the hydrophilic coating is made of polyacrylamide. The product is sterilized by ethylene oxide and is single-use.
产品由管身（带接头）、单向阀、球囊、涂层、导尿管塞（选配）、导丝（选配）组成。其中，管身（带接头）和球囊材质为乳胶，涂层包含合金涂层和亲水涂层，合金涂层材质为金银钯合金，亲水涂层材质为聚丙烯酰胺。产品经环氧乙烷灭菌，一次性使用。