recently, the disposable distal access catheter for neurological intervention and peripheral interventional therapy which is independent developed by the sub-company shanghai puhui medical instruments co. ltd. has obtained the class iii medical device registration certificate from national medical products administration of china (nmpa):
certificate no: 20213030233
registrant: shanghai puhui medical instruments co. ltd.
registrant location: area 207c, 2nd floor, building 2, shanghai no.925, jinyuan yi road, jiading district, shanghai
manufacturing location: area c, 2nd floor, building 2, shanghai no.925, jinyuan yi road, jiading district, shanghai
product name: disposable distal access catheter
composition and components: the catheter is designed with single lumen catheter shaft with hydrophilic coating, protective cover, luer hub and radiopaque marker band. the product is sterilized with ethylene oxide for single use and valid for 3 years.
applications: the distal access catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems.
approval date: april 8th, 2021
expiration date: april 7th, 2026
the approval of the above registration certificate further improved our company's product pipeline layout in the field of neurological intervention and peripheral intervention. in the future, our company will maintain "to be a world-renowned interventional and implantable medical device group led by scientific and technological innovation" as our development vision, continue to uphold the development concept of "innovation serves health, high-quality achieves excellence", and contribute to the development of china's medical device industry!