It took fewer than five years for Brosmed to distribute products over 40 countries and regions. So far, BrosMed is the only Chinese brand that provides high-end medical devices in the US, Japan and EU areas.
Timeline of BrosMed Medical FDA 510(k) Clearance and PMDA Approval in Global Market：
1. In July 16, 2013, BrosMed Received FDA Initial Registration for Facility Establishment.
2. In September 17, 2014, BrosMed Announces FDA 510(k) Clearance and Launch for Artimes™ Balloon Dilatation Catheter in the North America and Global Market.
3. In October 8, 2014, BrosMed Announces FDA 510(k) Clearance and Launch for Apollo™ Balloon Dilatation Catheter in the North America and Global Market.
4. In August 3rd, 2016, BrosMed Announces FDA 510(k) Clearance and Launch of Atropos™ 0.035 OTW PTA, Minerva™ 0.018 OTW PTA and Polux™ 0.014 OTW PTA Balloon Dilatation Catheters.
5. In August 8th, 2016, BrosMed Announces FDA 510(k) Clearance and Launch of Additonal Configurations Apollo™ NC PTCA Balloon Catheters in Unitied States and North Amercia Market.
6. In December 14, 2016, BrosMed Announces FDA 510(k) Clearance and Launch of Hermes™ NC 0.035 OTW PTA, Achilles™ NC 0.018 OTW PTA and Castor™ NC 0.014 OTW PTA Balloon Dilatation Catheters.
7. In Aug 30th , 2017, BrosMed Medical Announces PMDA Approval and Launch of Artimes™ and Apollo™ PTCA In Japan Market. These two balloons are designed for the treatment of percutaneous transluminal coronary angioplasty (PTCA) for the purpose of improving myocardial blood flow in the localized stenotic lesion of the coronary arteries. Following the approval, BrosMed Medical achieves one more step to its global vision beside current geographical footprint in Europe, USA, China, Asia Pacific, Latin America and Middle East.
8. In April 28th, 2018, BrosMed Medical Announces Completes Successful FDA Inspection. This comes as a result of Brosmed medical 5 years ongoing commitment to the highest levels of quality standards.
Exhibitor Data Sheet