Haiyan Kangyuan Medical Mea hana Ua loaʻa maikaʻi i Co., Ltd. nā lula o ka lāʻau lapaʻau EU (EU 2017/745, i kapa ʻia ʻo "MDR") palapala ma Pepeluali 1, 2023, ʻo ka helu palapala ʻo 6122159CE01, a ʻo ke ʻano o ka hōʻoia e pili ana i nā Endotracheal Tubes no ka hoʻohana hoʻokahi, Sterile Suction Catheter no ka hoʻohana ʻana i ka Masks Oxygen Nagen. ʻO Guedel Airways no ka hoʻohana hoʻokahi, Laryngeal Mask Airways, Anesthesia Masks no ka hoʻohana hoʻokahi, nā kānana hanu no ka hoʻohana hoʻokahi, nā kaapuni hanu no ka hoʻohana hoʻokahi.

Ua hōʻike ʻia ua hoʻokō ʻia ka EU Medical Instrument Regulation MDR (EU 2017/745) i Mei 25, 2017, e pani ana i ka Medical Instrument Directive MDD (93/42/EEC) a me ka Active Implantable Medical Instrument Directive AIMDD (90/385/EEC), e manaʻo ana e hoʻokumu i kahi kūlana olakino a me ka palekana o ka lehulehu. Ma waena o lākou, ua kau ʻo MDR i nā koi koʻikoʻi no nā mea hana lāʻau lapaʻau e pili ana i ka hoʻokele pilikia o ka huahana, ka hana huahana a me nā kūlana palekana, loiloi loiloi, a me ka makaʻala a me ka nānā ʻana ma hope o ka mākeke. Ke hoʻohālikelike ʻia me ke kuhikuhi MDD, ʻoi aku ka ikaika o ka MDR hoʻoponopono, ʻoi aku ka paʻakikī o ka hōʻoia ʻana, a nānā nui i ka palekana a me ka pono o nā huahana.

Ua loaʻa maikaʻi ʻo Kangyuan Medical i ka palapala MDR i kēia manawa, ka mea e hōʻoiaʻiʻo nei ua hōʻea nā huahana Kangyuan i ka ʻike ʻia o ka EU a me nā mākeke honua ma ke ʻano o ka mana hana, hōʻoia maikaʻi a me ka hoʻokele pilikia.

No Kangyuan Medical, ka mea i komo nui i ka mākeke ʻEulopa no nā makahiki he ʻumi, ʻo ka loaʻa ʻana o ka palapala MDR he mea nui. , Latin America a me nā mākeke ʻē aʻe i hāʻawi i ke kākoʻo ikaika.