News
25
2014-02
BrosMed Announces CE Mark and Launch for Apollo™ Balloon Dilatation Catheter
February 25, 2014— Following the CE approval and launch Artimes™ Balloon Dilatation Catheter, BrosMed announced CE Mark and Launch of its Apollo™ Balloon Dilatation Catheter which is now approved in the EU for the interventional cardiovascular use.
2014-02-25
21
2013-10
BrosMed Announces CE Mark and Launch for Artimes™ Balloon Dilatation Catheter
October 19, 2013– BrosMed announced CE Mark and launch of its Artimes™ Balloon Dilatation Catheter, which is now approved in the EU for the of improving myocardial blood flow in the localized stenotic lesion of the coronary arteries.
2013-10-21
16
2013-07
BrosMed Received FDA Initial Registration for Facility Establishment
July 16, 2013, BrosMed announced that the company received registration notification identifying BrosMed Medical facility establishment by the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH). The owner operator number is 10044695. Currently company is pursuing FDA approval for a series of products in order to enter North America markets.
2013-07-16
15
2013-07
BrosMed Received Registration Number from Dun & Bradstreet
July 10, 2013– BrosMed received the registration number (D-U-N-S: 42-131-8800) from the Dun & Bradstreet Corporation,(NYSE：DNB)
2013-07-15
24
2013-01
BrosMed received the formal certificates of ISO13485 & ISO 9001
On Jan, 23th, 2013, BrosMed Medical received the formal quality management system certificates of ISO13485:2003 and ISO9001:2008 from InterTek. BrosMed Medical has been passed the on-site pre-audit in Jun, 2012 and passed the on-site final audit in end of Sep., 2012.
2013-01-24
25
2012-06
Brosmed Passes on-site audit for the ISO13485 and ISO90001 certification
On July 25, BrosMed Medical successfully passes the on-site audit conducted by the Notified Body (Intertek) for the ISO 13485 and ISO90001 certification.
2012-06-25
12
2012-06
Local officials visit BrosMed Medical
On July 12, Local officials visited BrosMed Medical and are impressed by the high quality of the construction and design. The officials said “it is the first time they understand how the cardiovascular cathether is being built”.
2012-06-12
01
2012-03
on March the 3rd, Brosmed Medical has opened its new facility.
2012-03-01