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 yeFoley yeSingle, Sebenzisa i-silicone ye-Singleif. Iindlela ezi-3 ze-silicone i-foley catheter, i-2 indlela ye-silicone ye-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).

Isatifikethi se-EU MDR sibonisa ukuba iimveliso ze-Kangyuan Medical zihlangabezana neemfuno ze-EU zamva nje ze-2017/745, zineemeko zokufikelela zamva nje zeemarike ze-EU, kwaye zinokuqhubeka zithengiswa ngokusemthethweni kwiimarike ezichaphazelekayo zaphesheya, ukubeka isiseko esiluqilima sokungena ngakumbi kwimarike yaseYurophu kunye nokukhuthaza inkqubo yokuthengiswa kwamanye amazwe.
Ixesha lokuposa: Jul-26-2023
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