Izindaba Ezinhle！IVDR CECukuqinisekiswa kwe-ACCUGENCE®Pimikhiqizo  

Ngomhlaka-11 Okthoba, i-ACCUGENCE Multi-Monitoring System ACCUGENCE® Multi-Monitoring Meter (i-ACCUGENCE Blood Glucose, i-Ketone kanye ne-Uric Acid Analysis System, okuhlanganisa i-Meter PM900, i-Blood Glucose Strips SM211, i-Blood Ketone Strips SM311, i-Uric Acid Strips SM411, njll.)waphumelela isitifiketi seKlasi C se-IVDR.

Ngokuthola isitifiketi se-IVDR CE esikhishwe yi-TÜV SÜD, inhlangano eyazisiwe ye-European Union, okuyisinyathelo esibalulekile nesibalulekile ekuthuthukisweni kwe-ACCUGENCE®, futhi kuphawula intuthuko enkulu enkambisweni yokuhlola imakethe yaphesheya kwe-e-LinkCare.

Mayelana ne-IVDR

Umthethonqubo We-EU In Vitro Diagnostic Medical Devices Regulation (IVDR), owaqala ukusebenza ngoMeyi 25, 2017 futhi waqaliswa ngoMeyi 26, 2022, unezidingo ezibanzi neziqinile zokubuyekezwa kobuchwepheshe, ukuhlolwa kwezokwelapha, kanye nokuphathwa kwemakethe kwamadivayisi ezokwelapha okuxilonga ngaphakathi kwe-vitro ukuqinisekisa ukuphepha, ukusebenza kahle, kanye nekhwalithi yemikhiqizo.

Ngokusho kwemithethonqubo ye-EU yokuxilonga idivayisi yezokwelapha e-in vitro, ukuthola isitifiketi se-IVDR CE kuyisimo esidingekayo ukuze umkhiqizo ufinyelele emakethe ye-EU, okungukuthi, umkhiqizo uthole "i-visa" yokungena emakethe yaseYurophu.

Iqiniso lokuthi imikhiqizo yethu ingathola isitifiketi se-IVDR CE libonisa ukuthi i-ACCUGENCE yethu®Uhlelo Lokuqapha Oluningi luhlangabezane nezidingo ezisezingeni eliphezulu zemakethe ye-European Union maqondana nekhwalithi yomkhiqizo, ukuphepha kanye nokusebenza kahle, kanye nezinga lobuchwepheshe, kanyefuthiizinga lokulawula ikhwalithi selifinyelele amazinga omhlaba wonke.