中文Muva nje, i-Haiyan Kangyuan MedicalInsimbi I-Co., Ltd. ithole ngempumelelo isitifiketi sesitifiketi se-CE se-EU Medical Device Regulation 2017/745 (okubizwa ngokuthi "MDR") kwesinye "open-t".ip i-urinary catheter (eyaziwa nangokuthi: nephrostomy tube)" umkhiqizo. Njengamanje, i-Kangyuan Medical inemikhiqizo engu-13 ephumelele isitifiketi se-MDR,njengangezansi:
[Endotracheal Tubes for Single Use];
[Ama-Catheter Amunca Oyinyumba Okusetshenziswa Kanye];
[Izifihla-moya Zomoya Zokusetshenziswa Kanye];
[AmaCannula Oxygen Wamakhala Okusetshenziswa Kanye];
[I-Guedel Airways for Single Use];
[I-Laryngeal Mask Airways];
[Imaski Yokubulala Izinzwa Zokusetshenziswa Kanye];
[Izihlungi Zokuphefumula Zokusetshenziswa Okukodwa];
[Iziyingi Zokuphefumula Zokusetshenziswa Okukodwa];
[Ama-Urinary Catheter for Use single (Foley)];
[Latex Foley Catheters for Single Use];
[PVC Laryngeal Mask Airways];
[I-Suprapubic Catheter for Use single]
Ukuthola isitifiketi se-EU MDR akusho nje ukuthi i-Kangyuan Medical iwine "ukudlula" emakethe ye-EU ngezindinganiso eziqinile, kodwa futhi kubonisa ukuthi i-Kangyuan ifinyelele izinga elihamba phambili lamazwe ngamazwe emkhakheni wemishini yezokwelapha. Isitifiketi se-EU MDR sinezidingo eziqine kakhulu zekhwalithi yomkhiqizo, ukusebenza kokuphepha, idatha yomtholampilo nezinye izici. Ikhono le-Kangyuan Medical lokuphasa isitifiketi libonisa amandla ayo aqinile ezobuchwepheshe kanye nekhwalithi yomkhiqizo ovelele. Isitifiketi se-MDR sizosiza i-Kangyuan Medical ivule ngokujulile imakethe ye-EU futhi ithuthukise isithunzi samazwe ngamazwe somkhiqizo. Ngaso leso sikhathi, iphinde ikhuthaze i-Kangyuan Medical ukuthi ijulise ngokuqhubekayo ukuphathwa kwayo kokuthobelana kwezobuchwepheshe, isheshise ukuqanjwa kabusha kwezobuchwepheshe, futhi ikhuthaze ukuhlelwa kwayo kwamasu omhlaba ngezindinganiso eziphakeme, ngaleyo ndlela kwakhiwe umugqa wokuzivikela oqine kakhudlwana wezempilo nokuphepha kwabathengi bomhlaba.
Isikhathi sokuthumela: May-14-2025