Hemodialyzer - NMPA Registration 国械注准20243101182
Access comprehensive regulatory information for Hemodialyzer 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20243101182 and owned by Jiangxi HONGDA MEDICAL Equipment Group Ltd.. The device was approved on June 20, 2024.
This page provides complete registration details including registrant information, province location (Jiangxi), 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 hemodialysis treatment of acute and chronic renal failure.
适用于急慢性肾功能衰竭的血液透析治疗。
The hemodialyzer consists of a shell, a dialysis membrane, an end cap, an O-ring, a sealing gel, and a protective cap. The dialysis membrane is made of polyethersulfone material, the shell and end cap are made of polycarbonate material, the O-ring is made of silicone rubber material, the sealing glue is made of polyurethane rubber material, and the protective cover is made of polypropylene material. The product is sterile after radiation sterilization.
血液透析器由外壳、透析膜、端盖、O形圈、封口胶、保护盖组成。透析膜采用聚醚砜材料，外壳和端盖采用聚碳酸酯材料，O形圈采用硅橡胶材料，封口胶采用聚氨酯胶材料，保护盖采用聚丙烯材料。经辐射灭菌，产品无菌。