E ai ki te korero kua angitu a Haiyan Kangyuan Medical Instrument Co., Ltd. i te tiwhikete CE o te EU Medical Device Regulation 2017/745 (e kiia ana ko "MDR") i nga hua e rua i tera marama. Ko nga hua ko te PVC Laryngeal Mask Airways me te Latex Foley Catheters mo te Whakamahi Kotahi. I tenei wa, 12 nga hua o Kangyuan Medical kua paahitia te tiwhikete MDR, e whai ake nei:

[Ngongo Endotracheal mo te Whakamahi Kotahi];

[Katetere Momo Maama mo te Whakamahi Kotahi];

[Maki Oxygen mo te Whakamahi Kotahi];

[Nasal Oxygen Cannulas for Single Use];

[Guedel Airways mo te Whakamahi Takitahi];

[Laryngeal Mask Airways];

[Maki Whakamaori mo te Whakamahi Kotahi];

[Tatari Manawa mo te Whakamahi Kotahi];

[Rangi Manawa mo te Whakamahi Kotahi];

[Urinary Catheters for Single Use (Foley)];

[Latex Foley Catheters mo te Whakamahi Takitahi];

[PVC Laryngeal Mask Airways]

 

Ko te tiwhikete EU MDR e whakaatu ana ko nga hua rongoa a Kangyuan te whakatutuki i nga whakaritenga o te ture taputapu hauora hou a EU 2017/745 me nga tikanga whakauru hou mo te maakete EU. Ehara tenei i te tino whakanui i te kounga, te haumaru me te whai hua o nga hua rongoa Kangyuan, engari he whakaata nui ano mo te kaha hangarau o te kamupene me te whakataetae maakete. Ka whai waahi a Kangyuan Medical ki te whakawhānui ake i te maakete a te Pakeha me te whakarato i nga ratonga hauora kounga teitei ake ki te maha atu o nga turoro puta noa i te ao.