Muva nje, i-Haiyan Kangyuan Medical instrument Co., Ltd. iqedele isichibiyelo sokubhaliswa kwe-CE ngaphansi koMthethonqubo Wedivayisi Yezokwelapha we-EU 2017/745 (ozobizwa ngokuthi “i-MDR”) wemikhiqizo yayo ye-catheter yomchamo ye-silicone elahlwayo. Ngokwakhela ekubhalisweni kwayo okukhona, inkampani ingeze amamodeli amathathu emikhiqizo emisha futhi yandisa ngokuhlelekile ububanzi bamabhaluni atholakalayo; le mikhiqizo manje isilungele ngokusemthethweni ukuqaliswa emakethe ngokushesha.

Lokhu kwanda kwezinombolo zamamodeli abhalisiwe e-MDR zama-catheter omchamo we-silicone kugqamisa amandla amasha e-Kangyuan Medical ngaphakathi kwezigaba zokwelapha ezikhethekile. Ukuqhubekela phambili, i-Kangyuan Medical izoqhubeka nokugxila emizamweni yayo ezintweni ezingokoqobo zezokwelapha futhi isebenzise iphothifoliyo yayo yomkhiqizo ephelele ukuguqula "ukwenza ngokwezifiso okunembile" kusuka emqondweni kuya kuzo zonke izigaba zohambo lwayo lokusungula izinto ezintsha lwe-R&D, iletha izixazululo eziqinile embonini yezempilo yomhlaba wonke.