Брошюры

On Call Sure Blood Glucose Monitoring System IDK (Germany) Evaluation Report
On Call Sharp Blood Glucose Monitoring System IDT (Germany) Evaluation Report
On Call Plus Blood Glucose Monitoring System NHS (UK) Evaluation Report
h10.jpg h11.jpg h12.jpg

Quality System

US FDA

1) Passed US FDA inspections in the past 3 consecutive times (2008 & 2016 with “Zero Defect”)
2) Comply with CGMP/QSR requirements
h1.jpg

CE

1) Comply with IVDD 98/79/EC
2) Comply with MDD 93/42/EEC
3) EN ISO 13485:2016 certified
h2.jpg

Comply with NMPA regulatory requirements

Passed a variety of authorities on-site audits from different countries

Germany TÜV SÜD, Brazil ANVISA, Korea FDA, Ukraine MOH, France LNE, Nigeria FDA, GCC SGH, Iran MOH, etc.
2-04.jpg h4.jpg

Сертификаты на продукцию

US FDA cleared
CE cleared
CFDA/FSC certified
ISO15197 certified
MDSS certified
h5.jpg h6.jpg h7.jpg h8.jpg h9.jpg