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2nd building, SMEs Venture Park

SongShan Lake Hi-Tech Industrial

Development Zone

Dongguan

523808

China

Certificate/license number Standard/scheme number or name Start date Expiry date
Certificate/license number MD 647941 Standard/scheme number or name ISO 13485:2016 & EN ISO 13485 Start date 2016-08-22 Expiry date 2028-08-21
Scope
Manufacture and sterilization of PTCA Coronary Balloon Dilatation Catheters, PTA Balloon Dilatation Catheters, Hydrophilic Guide Wires, Catheter Sheath Introducer, Accessories, Microcatheters and Neurovascular Catheters. Manufacture of Drug-Coated Balloon Dilatation Catheters.
PTCA 冠脉球囊扩张导管、PTA外周球囊扩张导管、亲水导丝、导管鞘、配件、微导管和神经血管导管的制造和灭菌。药物涂层球囊扩张导管的制造。

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