Kutshanje, Haiyan Kangyuan MedicalIsixhobo I-Co., Ltd. iphumelele isiqinisekiso se-CE se-EU Medical Device Regulation 2017/745 (ekubhekiselwa kuyo njenge "MDR") kwenye "open-tip I-catheter yomchamo (ekwaziwa njenge: nephrostomy tube)" imveliso. Okwangoku, iKangyuan Medical ineemveliso ezili-13 eziphumelele isiqinisekiso se-MDR,njengoko kungezantsi:
[Iibhubhu ze-Endotracheal zokusetyenziswa okukodwa];
[IiCatheter zokufunxa iiNtsholongwane eziNdlwengulo ezisetyenziselwa into enye];
[IiMaski zeoksijini ezisetyenziselwa uSetyenziso olunye];
[IiCannulas zeOxygen eempumlweni zokusetyenziswa kanye];
[IiNqwelo zomoya zeGuedel zosetyenziso olulodwa];
[I-Laryngeal Mask Airways];
[IiMaski zokuthomalalisa ukuze zisetyenziswe kanye];
[Izihluzi zokuphefumla ezisetyenziselwa usetyenziso olunye];
[Iisekethe zokuphefumla ezisetyenziselwa usetyenziso olunye];
[IiCatheter zokuChama ezisetyenziselwa kanye (Foley)];
[IiCatheter zeLatex Foley zokuSebenzisa olunye];
[PVC Laryngeal Mask Airways];
[IiCatheter zeSuprapubic zokuSebenzisa olunye]
Ukufumana isatifikethi se-EU MDR akuthethi nje ukuba i-Kangyuan Medical iphumelele "ukudlula" kwimarike ye-EU kunye nemigangatho engqongqo, kodwa ibonisa ukuba i-Kangyuan ifikelele kwinqanaba eliphambili lamazwe ngamazwe kwinkalo yezixhobo zonyango. Isatifikethi se-EU MDR sineemfuno ezingqongqo kakhulu kumgangatho wemveliso, ukusebenza kokhuseleko, idatha yezonyango kunye neminye imiba. Ukukwazi kweKangyuan Medical ukupasa isiqinisekiso kubonisa amandla ayo obugcisa obuqinileyo kunye nomgangatho obalaseleyo wemveliso. Ukuqinisekiswa kwe-MDR kuya kunceda i-Kangyuan Medical ukuvula ngokunzulu imarike ye-EU kunye nokwandisa igama le-brand kumazwe ngamazwe. Kwangaxeshanye, ikwakhuthaza iKangyuan Medical ukuba iqhubeke yenze nzulu ulawulo lwayo lokuthotyelwa kobugcisa, ikhawulezise iteknoloji entsha, kwaye ikhuthaze uyilo lwayo lweqhinga lamazwe ngamazwe ngemigangatho ephezulu, ngaloo ndlela isakha umgca wokhuseleko oqinileyo ngakumbi kwimpilo nokhuseleko lwabathengi behlabathi.
Ixesha lokuposa: May-14-2025
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