our company has recently obtained the class iii medical device registration certificate from national medical products administration of china (nmpa) for transradial introducer set with hydrophilic coating:
certificate no: 20203031014
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: transradial introducer set
composition and components: introducer sheath, dilator, guidewire, puncture needle and guide sleeve. the product is sterilized with ethylene oxide, provided aseptically and disposable; the product is valid for 3 years.
applications: it is used to enlarge the percutaneous incision of the radial artery in interventional operation to establish the channel for catheters insertion into the blood vessel
approval date: december 31th, 2020
expiration date: december 30th, 2025
the above-mentioned products are upgraded products of our company's original transradial introducer set. on the basis of the original products, our company has added a hydrophilic coating on the surface of the product, which can effectively avoid damage to blood vessels. the approval of the product registration certificate is an effective supplement to our company's existing interventional product line and is of positive significance to our company's development in the field of cardiovascular intervention therapy.