Kuxelwa ukuba i-Haiyan Kangyuan Medical Instrument Co., Ltd. uye wafumana ngempumelelo isatifikethi se-CE se-EU Medical Device Regulation 2017/745 (ebizwa ngokuba yi "MDR") kwiimveliso ezimbini kwinyanga ephelileyo. Iimveliso zePVC Laryngeal Mask Airways kunye neLatex Foley Catheters yosetyenziso olulodwa. Okwangoku, iimveliso ze-12 ze-Kangyuan Medical ziphumelele isatifikethi se-MDR, ezi zilandelayo:

[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 zokusetyenziswa okukodwa];

[IiCatheter zokuChama ezisetyenziselwa kanye (Foley)];

[IiCatheter zeLatex Foley zokuSebenzisa olunye];

[PVC Laryngeal Mask Airways]

 

Isatifikethi se-EU MDR sibonisa ukuba i-Kangyuan Medical imveliso ihlangabezana neemfuno ze-EU yamva nje yommiselo wesixhobo sonyango se-2017/745 kwaye ineemeko zokufikelela zakutsha nje kwimarike ye-EU. Oku akukona nje ukuqondwa okuphezulu komgangatho, ukhuseleko kunye nokusebenza kakuhle kweemveliso zonyango zaseKangyuan, kodwa kunye nomboniso obalulekileyo wamandla obugcisa benkampani kunye nokhuphiswano lwemarike. I-Kangyuan Medical iya kuthatha eli thuba ukwandisa ngakumbi imarike yaseYurophu kwaye ibonelele ngeenkonzo zonyango ezikumgangatho ophezulu kwizigulana ezininzi kwihlabathi jikelele.