Haiyan Kangyuan Medical Taputapu Co., Ltd. i angitu te whiwhi i nga ture taputapu hauora a te EU (EU 2017/745, e kiia ana ko "MDR") te tiwhikete i te Hui-tanguru 1, 2023, ko te nama tiwhikete ko 6122159CE01, me te waahi o te tiwhikete kei roto i nga Endotracheal Tubes mo te Whakamahi Kotahi, Ko te Kaitapa Whakamoana Tuturu mo te Whakamahinga Kotahi, Ko nga Maaka Oxygen mo te Whakamahi Kotahi, Nasal Oxygen Cannulas mo te Whakamahinga Kotahi, Guedel Airways mo te Whakamahinga Kotahi, Laryngeal Mask Airways, Anesthesia Masks mo te Whakamahinga Takitahi, Nga whiriwhiringa manawa mo te Whakamahinga Takitahi, Nga porowhita manawa mo te Whakamahi Kotahi.

E ai ki te korero ko te EU Medical Instrument Regulation MDR (EU 2017/745) i whai mana i te Mei 25, 2017, hei whakakapi i te Medical Instrument Directive MDD (93/42/EEC) me te Active Implantable Medical Instrument Directive AIMDD (90/385). /EEC ), e whai ana ki te whakatu i tetahi anga ture hou me te kaha ake kia pai ake te tiaki i te hauora me te haumaru o te iwi whanui me nga turoro. I roto i a raatau, kua tukuna e te MDR nga whakaritenga kaha mo nga kaihanga taputapu rongoa mo te whakahaere morearea o te hua, te mahi hua me nga paerewa haumaru, te arotake haumanu, me te maataki i muri i te maakete me te tirotiro. Ina whakaritea ki te tohutohu MDD, he kaha ake te tirotiro a te MDR ture, he uaua ake te tiwhikete, me te aro nui ki te haumaru me te whai hua o nga hua.

Kua angitu a Kangyuan Medical i te tiwhikete MDR i tenei wa, e tino whakaatu ana kua tae nga hua Kangyuan ki te mohiotanga o te EU me nga maakete o te ao mo te mana whakahaere, te kounga o te kounga me te whakahaere morearea.

Mo Kangyuan Medical, kua tino whai waahi ki te maakete Pakeha mo te neke atu i te tekau tau, ko te whiwhinga o te tiwhikete MDR he tohu nui. , Amerika Latina me etahi atu maakete i tautoko kaha.