PTCA balloon dilation catheter obtained Registration Certificate for Class III
2019-04-17
Our company has recently obtained “Peoples Republic of China Registration Certificate for Medical Device”, the details are as follows:
Certificate No: 20193030239
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: PTCA balloon dilation catheter
Composition and components: This product is Rx type balloon dilation catheter which consists of tapered tip, marking, balloon, distal outer shaft, core wire with loop, hypotube and etc. It is covered with hydrophilic coating and sterilized with epoxy ethane, intended for single use only and has a shelf time of 3 years.
Applications: Used to treat the narrowing of coronary arteries or dilation in stent.
Note: product No.6877 in previous catalog
Approval Date: April 16th,2019
Expiration Date: April 15tb,2024