News

News

10

2014-07

BrosMed Announces CE Mark and Launch for Full Range of Accessories for Cardiology and Radiology Procedures

July, 10, 2014— Following the CE approval and launch Artimes™ and Apollo™ Balloon Dilatation Catheter, BrosMed announced CE Mark and Launch of Fourteen (14) types of interventional accessories which are now approved in EU for the cardiology and radiology procedures.

2014-07-10

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 purpose 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 January 23, 2013, BrosMed Medical was officially awarded ISO13485:2003 and ISO9001:2008 quality management system certifications by InterTek. Prior to the certification, the company successfully completed the on-site pre-audit in Jun 2012 and the final audit in September 2012.

2013-01-24

25

2012-06

Brosmed Passes on-site audit for the ISO13485 and ISO9001 certification

On July 25, BrosMed Medical successfully passes the on-site audit conducted by Intertek for ISO 13485 and ISO9001 certification.

2012-06-25

12

2012-06

Local officials visit BrosMed Medical

On July 12, local officials visited BrosMed Medical and were impressed by the high quality of the facility's construction and design. The officials commented that it was their first time seeing how the cardiovascular cathethers are manufactured.

2012-06-12

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