Iindaba ezimnandi！IVDR CECukuqinisekiswa kwe-ACCUGENCE®Piimveliso  

Ngomhla we-11 kuOkthobha, i-ACCUGENCE Multi-Monitoring System ACCUGENCE® Multi-Monitoring Meter (i-ACCUGENCE Blood Glucose, iKetone kunye ne-Uric Acid Analysis System, kuquka iMeter PM900, iiBlood Glucose Strips SM211, iiBlood Ketone Strips SM311, iiUric Acid Strips SM411, njl.njl.)uphumelele isiqinisekiso seKlasi C se-IVDR.

Ngokufumana isatifikethi se-IVDR CE esikhutshwe yi-TÜV SÜD, umbutho onolwazi lwe-European Union, elinyathelo elibalulekileyo nelibalulekileyo kwinkqubela phambili ye-ACCUGENCE®, kwaye liphawula impumelelo enkulu kwinkqubo yokuhlola imakethi yaphesheya ye-e-LinkCare.

Malunga ne-IVDR

UMthetho we-EU In Vitro Diagnostic Medical Devices Regulation (IVDR), owaqala ukusebenza ngoMeyi 25, 2017 waza wasebenza ngoMeyi 26, 2022, uneemfuno ezibanzi nezingqongqo zophononongo lobuchwephesha, uvavanyo lweklinikhi, kunye nolawulo lwemarike lwezixhobo zonyango zokuxilonga kwi-vitro ukuqinisekisa ukhuseleko, ukusebenza kakuhle, kunye nomgangatho weemveliso.

Ngokwemigaqo ye-EU yezixhobo zonyango zokuxilonga kwi-vitro, ukufumana isiqinisekiso se-IVDR CE kuyimfuneko yokufikelela kwimveliso kwimarike ye-EU, oko kukuthi, imveliso ifumene "i-visa" yokungena kwimarike yaseYurophu.

Inyani yokuba iimveliso zethu zinokufumana isiqinisekiso se-IVDR CE ibonisa ukuba i-ACCUGENCE yethu®Inkqubo yokubeka esweni izinto ezininzi ihlangabezane neemfuno ezisemgangathweni ophezulu zemarike ye-European Union ngokubhekiselele kumgangatho wemveliso, ukhuseleko kunye nokusebenza kakuhle, kunye nenqanaba lobugcisa, kunyekwakhonainqanaba lolawulo lomgangatho lifikelele kwimigangatho yamazwe ngamazwe.