Indications for Use StatementMedical Face Mask is Intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of micro organisms, body fluids and particulate material. About Medical Face Mask510(k) Number: K201601Regulation Number: 878.4040Classification Product Code: FXX...
2021.01
Our company's Shanghai Puhui Medical Instruments Co. Ltd. has recently obtained one National Medical Products Administration of China registration certificate for Class III medical device as below. Certificate No: 20203030984 Registrant: Shanghai Puhui Medical Instruments Co. Ltd. Registrant Location: No.925, Jinyuan Yi Road, Jiading District, Shanghai Manufacturing Locatio...
2020.12
We obtained four European CE certificates for Class III medical devices recently, including cardiovascular angiography catheter, guiding catheter, micro catheter and cardiovascular guidewire. As at December 31th, 2020, we have an aggregate of 39 European CE certificates. The company will continue to use its own R&D advantages to continue to provide overseas customers with better...
2020.12
On December 30th, 2020, our company signed an investment agreement with Rizhao Economic and Technological Development Zone, and KDL Medical-Rizhao Innovative Medical Device Industrial Park (“Industrial Park”) officially settled in Rizhao Economic Development Zone. The Industrial Park aims to build an innovative medical device industrial park with multiple platforms, includinginterventional medic...
2020.12
Indications for Use StatementKDL Angiography Catheter is used to provide support, to facilitate the placement of guidewires in the peripheral and coronary vasculature, and can be used to exchange one guidewire for another. It is also intended to assist in the delivery of diagnostics, embolic, or therapeutic materials into peripheral and coronary vessels. About KDL Angiography C...
2020.11
On November 8th, 2020, the "Hongqiao International Innovative Medical Device Industrial Park" (“Industrial Park”), which is operated by the Company, grandly laid the foundation stone in Jiangqiao Town, Jiading District, Shanghai. Dr. Liang Dongke, our chairman and general manager, led the Company team to the ceremony with our valued guests. Dr. Liang Dongke made a speech at the ce...
2020.11
Our company has recently obtained “Peoples Republic of China Registration Certificate for Medical Device”, the details are as follows: Certificate No: 20202040468 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, Jiadi...
2020.09
Indications for Use StatementInflation Device is intended to be used in PTCA or PTA procedures to create and monitor pressure in the balloon and to deflate the balloon dilatation catheter. About Inflation Device510(k) Number: K170027Regulation Number: 870.1650Classification Product Code: MAVDate Received: 01/03/2017Decision Date: 10/06/...
2020.10
On August 25th, 2020, through the acceptance platform of the Shanghai Municipal State-owned Construction Land Use Right Transfer Online Transaction System, our company won the bid for the Shanghai Jiading District Planning and Natural Resources Bureau to publicly sell the land name as 1906 Jiangqiao Town, Jiading District. The right to use the state-owned construction land for the land No. (Plot A...
2020.08
Our company has recently obtained “Peoples Republic of China Registration Certificate for Medical Device”, the details are as follows: Certificate No: 20202180314 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 Na...
2020.07