I-Haiyan Kangyuan Medical Instrument Co., Ltd. ifumene ngempumelelo i-European Union Medical Device Regulation 2017/745 (ekubhekiselwa kuyo njenge "MDR") isatifikethi se-CE ngoJulayi 19, 2023, inombolo yesatifikethi 6122159CE01, umda wesatifikethi yi-Urinary Catheters yoSetyenziso olulodwa. Foley), Ngokukodwa ibandakanya i-2 indlela ye-silicone foley catheter, i-3 indlela ye-silicone i-catheter ye-foley, i-2 indlela ye-silicone i-foley catheter ene-tiemann tip kunye ne-3 indlela ye-silicone foley catheter ene-coude tip. Okwangoku, i-Kangyuan Medical iphumelele iimveliso ze-MDR:

Imibhobho ye-Endotracheal yokusetyenziswa okukodwa;

IiCatheters eziNtsholongwane zokuSebenzisa enye;

Iimaski zeoksijini zokusetyenziswa okukodwa;

IiCannulas ze-Oxygen zeNasal zokusetyenziswa okukodwa;

I-Guedel Airways yosetyenziso olulodwa;

I-Laryngeal Mask Airways;

Iimaski ze-Anesthesia zokusetyenziswa okukodwa;

Izihluzi zokuphefumla zokusetyenziswa okukodwa;

Iisekethe zokuphefumla zokusetyenziswa okukodwa;

IiCatheter zokuChama zokusetyenziswa okukodwa (Foley).

Isiqinisekiso se-EU MDR sibonisa ukuba iimveliso zoNyango zeKangyuan zihlangabezana neemfuno ze-EU yamva nje yommiselo wesixhobo sonyango se-2017/745, zineemeko zofikelelo zamva nje zeemarike ze-EU, kwaye zinokuqhubeka zithengiswa ngokusemthethweni kwiimarike ezifanelekileyo zaphesheya, zibeka isiseko esiluqilima ukungena ngakumbi kwimarike yaseYurophu kunye nokukhuthaza inkqubo yokwenziwa kwamazwe ngamazwe.