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Guide wire for single use obtained Registration Certificate for Class III

2019-08-01

Our company has recently obtained “Peoples Republic of China Registration Certificate for Medical Device”, the details are as follows:
Certificate No: 20193030562
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 wire for single use
Composition and components. Guide wire consists of guidewire, dispenser, platinum alloy coils, stainless steel coil, distal core, nitinol tube, proximal core. The head of the guidewire is covered with hydrophilic coating and sterilized with epoxy ethane. Each package contains one shaping needle. It is single use only and has a shelf period of 3 years.
Applications: Used as a passageway to guide PTCA balloon catheter or stent to lesion in PTCA or PTA surgery.
Note: product No.6877 in previous catalog
Approval Date: July 30th,2019
Expiration Date: July 29th,2024
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