Product Examples That We Act as a DMAH

・ECG monitor (USA)– ClassⅡ
・Multiparameter Monitor (China)– ClassⅡ
・Diagnostic Ultrasound Imaging (China) – ClassⅡ
・Electronic Stethoscope (Korea) – ClassⅡ
・Dental implant system (Korea) – Class III
・Single-use injection needle (Korea) – Class II
・Single-use infusion/drainage blunt needle (Korea) – Class II
・Radioactive compound synthesizing facilities (Belgium) – Class III
・Dental implant abutment (Korea) – Class III
・Dental synthetic resins for crown and bridge (Korea) – Class II ・Flexible video cystoscope (Denmark) – Class II
・Evacuated sealed blood collecting tube (Taiwan) – Class II ・Acrylic denture base resins (Korea) – Class II
・Drug/vaccine injection needle (China) – Class II
・Dental porcelain for machinable ceramic block (Korea) – Class II
・Total hip prosthesis (Korea) – Class III
・Dental implant suprastructure (Korea) – Class II
・Healing promoting material using human amnion (USA) – Class Ⅳ
・Vesicoureteral reflux treatment injectable material (USA) – Class III
・Single-use endoscopic injection needle (USA) – Class II

・Quality Inspection
・Labeling (Legal indication), Attaching of the “Package Insert”
・Shipment
・Inventory management
・Order management

Regulatory applications are supported by our parent company EXPARTNER JAPAN Co.,Ltd.