Mashoko Akanaka！IVDR CECkugadziriswa kweACCUGENCE®Pzvigadzirwa  

Musi wa11 Gumiguru, ACCUGENCE Multi-Monitoring System ACCUGENCE® Multi-Monitoring Meter (ACCUGENCE Blood Glucose, Ketone uye Uric Acid Analysis System, kusanganisira Meter PM900, Blood Glucose Strips SM211, Blood Ketone Strips SM311, Uric Acid Strips SM411, nezvimwewo)vakapasa chitupa cheClass C cheIVDR.

Nekuwana chitupa cheIVDR CE chakapihwa neTÜV SÜD, sangano reEuropean Union rakaziviswa, iro riri danho rakakosha uye rakakosha mukufambira mberi kweACCUGENCE®, uye rinoratidza budiriro huru mukutsvaga musika wekunze kwe e-LinkCare.

Nezve IVDR

Mutemo weEU In Vitro Diagnostic Medical Devices Regulation (IVDR), uyo wakatanga kushanda musi wa25 Chivabvu 2017 uye wakatanga kushanda musi wa26 Chivabvu 2022, une zvinodiwa zvakakwana uye zvakasimba zvekuongorora tekinoroji, kuongororwa kwekiriniki, uye kutarisirwa kwemusika kwemidziyo yekurapa inoongororwa mu vitro kuti ive nechokwadi chekuchengetedzwa, kushanda zvakanaka, uye mhando yezvigadzirwa.

Zvinoenderana nemitemo yeEU yekuongorora michina yekurapa mu vitro, kuwana chitupa cheIVDR CE chinhu chinodiwa kuti chigadzirwa chisvike kumusika weEU, kureva kuti, chigadzirwa chawana "vhiza" yekupinda mumusika weEurope.

Kugona kwezvigadzirwa zvedu kuwana chitupa cheIVDR CE kunoratidza kuti ACCUGENCE yedu®Sisitimu yeMulti-Monitoring yakasangana nezvinodiwa zvepamusoro zvemusika weEuropean Union maererano nemhando yechigadzirwa, kuchengetedzeka uye kushanda zvakanaka, pamwe nehunyanzvi, uyezvakaremwero wekudzora mhando wasvika padanho repasi rose.