I-Haiyan Kangyuan Medical Incensel Co, Ltd ithole ngempumelelo umthetho we-European Union Medical Regulation 2017/745 (Kubhekiselwe ku-As "MDR") NgoJulayi 19, 2022, Isitifiketi Sokuhlobisa Amakhethini Orinary ngokusetshenziswa okukodwa ( I-Foley), ikakhulukazi ifaka phakathi kwendlela engu-2 abicah foley catheter, 3 indlela kakhukhi we-silicone Foley Cathey ene-timemanch catheter ene-tiemanch tip kanye ne-3 abicone foley cathet. Njengamanje, ezokwelapha zaseKangyuan zidlulile imikhiqizo ye-MDR:
Amashubhu e-endotracheal ngokusetshenziswa okukodwa;
Ama-sterile sucrent Catheters asetshenziswa okukodwa;
Imaski ye-oksijini yokusetshenziswa okukodwa;
I-NASAL OXYGEN CANCANALAS YOKUSETYENZISWA KOKUSETYENZISWA KANYE;
I-Guedel Airways yokusetshenziswa okukodwa;
Ama-laryngeal mask airways;
Imaski ye-anesthesia yokusetshenziswa okukodwa;
Ukuphefumula izihlungi zokusebenzisa okukodwa;
Ukuphefumula amasekethe ukuze kusetshenziswe okukodwa;
Amakhekhe ama-Urinary asetshenziswa okukodwa (Foley).
Isitifiketi se-EU MDR sibonisa ukuthi imikhiqizo yezokwelapha yaseKangyuan ihlangabezana nezidingo ze-EU Medical Regugetion yakamuva ye-EU Medical Regulation 2017/745, zinokufinyelela kwakamuva kwemakethe ye-EU, futhi kungaqhubeka nokuthengiswa ngokusemthethweni ezimakethe ezifanele zakwa-Overseas, zibeka isisekelo esiqinile se Ukungena phambili emakethe yaseYurophu nokukhuthaza inqubo yamazwe omhlaba.
Isikhathi sePosi: Jul-26-2023