Ua hōʻike ʻia ua loaʻa maikaʻi ʻo Haiyan Kangyuan Medical Instrument Co., Ltd. i ka palapala CE o ka EU Medical Device Regulation 2017/745 (i kapa ʻia ʻo "MDR") i ʻelua huahana i ka mahina i hala. ʻO nā huahana PVC Laryngeal Mask Airways a me Latex Foley Catheters no ka hoʻohana hoʻokahi. I kēia manawa, ua hala nā huahana 12 o Kangyuan Medical i ka palapala MDR, ʻo ia hoʻi:

[Endotracheal Tubes for Single Use];

[Sterile Suction Catheters no ka hoohana hookahi];

[Oxygen Masks no ka hoʻohana hoʻokahi];

[Nasal Oxygen Cannulas no ka hoʻohana hoʻokahi];

[Guedel Airways no ka hoʻohana hoʻokahi];

[Laryngeal Mask Airways];

[Maka Anesthesia no ka hoʻohana hoʻokahi];

[Nā kānana hanu no ka hoʻohana hoʻokahi];

[Kaapuni hanu no ka hoohana hookahi];

[Urinary Catheters for Single Use (Foley)];

[Latex Foley Catheters no ka hoohana hookahi];

[PVC Laryngeal Mask Airways]

 

Hōʻike ka palapala EU MDR e hoʻokō nā huahana ʻo Kangyuan Medical i nā koi o ka hoʻoponopono lāʻau lapaʻau EU hou loa 2017/745 a loaʻa nā kūlana komo hou no ka mākeke EU. ʻAʻole kēia he ʻike kiʻekiʻe o ka maikaʻi, palekana a me ka maikaʻi o nā huahana lapaʻau Kangyuan, akā he hōʻike koʻikoʻi hoʻi o ka ikaika ʻenehana a me ka hoʻokūkū mākeke. E lawe ʻo Kangyuan Medical i kēia manawa e hoʻonui hou i ka mākeke ʻEulopa a hāʻawi i nā lawelawe lapaʻau kiʻekiʻe kiʻekiʻe i nā poʻe maʻi a puni ka honua.