Ozi Ọma!IVDR CECasambodo maka ACCUGENCE®Pngwaahịa  

Na ụbọchị iri na otu nke ọnwa Ọktoba, ACCUGENCE Multi-Monitoring System ACCUGENCE® Multi-Monitoring Meter (ACCUGENCE Blood Glucose, Ketone na Uric Acid Analysis System, gụnyere Meter PM900, Blood Glucose Strips SM211, Blood Ketone Strips SM311, Uric Acid Strips SM411, wdg)gafere asambodo Klas C nke IVDR.

Site n'inweta asambodo IVDR CE nke TÜV SÜD nyere, otu European Union mara ọkwa, nke bụ nzọụkwụ dị mkpa na nke dị mkpa na ọganihu nke ACCUGENCE®, ma gosipụta nnukwu ọganihu n'usoro inyocha ahịa e-LinkCare na mba ofesi.

Banyere IVDR

Iwu EU In Vitro Diagnostic Medical Devices Regulation (IVDR), nke malitere ịrụ ọrụ na Mee 25, 2017 ma tinye ya n'ọrụ na Mee 26, 2022, nwere ihe ndị zuru oke ma sie ike maka nyocha teknụzụ, nyocha ahụike, na nlekọta ahịa nke ngwaọrụ ahụike in vitro iji hụ na nchekwa, arụmọrụ, na ịdị mma nke ngwaahịa ndị ahụ.

Dịka iwu EU si dị na ngwaọrụ ahụike nchọpụta ọrịa in vitro, inweta asambodo CE nke IVDR bụ ihe dị mkpa maka ịnweta ngwaahịa na ahịa EU, ya bụ, ngwaahịa ahụ enwetala "visa" iji banye n'ahịa Europe.

Eziokwu ahụ bụ na ngwaahịa anyị nwere ike inweta asambodo IVDR CE na-egosi na AKWỤKWỌ anyị®Sistemụ Nlekota Ọtụtụ emezuola ihe achọrọ dị elu nke ahịa European Union n'ihe gbasara ịdị mma ngwaahịa, nchekwa na arụmọrụ, yana ọkwa teknụzụ, nanakwaọkwa njikwa àgwà erutela ọkwa mba ụwa.