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Guide catheter for single use obtained Registration Certificate for Class III

2019-12-20

Our company has recently obtained “Peoples Republic of China Registration Certificate for Medical Device”, the details are as follows:
Certificate No: 20193030955
Registrant: Shanghai Kindly Medical Instruments Co., Ltd.
Registrant Location: Building 2, No.925, Jinyuan Yi Road, Jiading District, Shanghai
Manufacturing Location: No.925, Jinyuan Yi Road, Jiading District, Shanghai
Product name: Guide catheter for single use
Composition and components: Main shaft, protector, hub and marker band. The main shaft has 3 layer, with or without side holes. Non-coated. Main shaft material including: Pebax, bismuth trioxide, BaSO, 304 stainless steel (middle layer) and PTFE (inner layer). Marker band contains Tungsten. ETO sterilized for single use, 3 year of shelf life.
Applications: Providing tunnel for interventional device and diagnostic device delivering during Percutaneous Transluminal Coronary Angioplasty
Approval Date: Dec 4th,2019
Expiration Date: Dec 3th,2024