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