中文I tata nei, Haiyan Kangyuan MedicalTaputapu Kua angitu a Co., Ltd. i te tiwhikete tohu CE o te EU Medical Device Regulation 2017/745 (e kiia ana ko "MDR") mo tetahi atu "tuwhera-tip urinary catheter (e mohiotia ana ano: nephrostomy tube)" hua. I tenei wa, he 13 nga hua a Kangyuan Medical kua paahitia te tohu MDR,penei i raro 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]；
[Katetere Suprapubic mo te Whakamahi Takitahi]
Ko te whiwhi i te tiwhikete MDR EU ehara i te mea kua riro i a Kangyuan Medical te "paahi" ki te maakete o te EU me nga paerewa kaha, engari e tohu ana kua eke a Kangyuan ki te taumata rangatira o te ao i roto i te waahi o nga taputapu rongoa. Ko te tiwhikete MDR EU he tino whakaritenga mo te kounga o te hua, te mahi haumaru, nga raraunga haumanu me etahi atu waahanga. Ko te kaha o Kangyuan Medical ki te tuku i te tiwhikete e whakaatu ana i tona kaha hangarau kaha me te kounga o te hua. Ko te tohu MDR ka awhina i a Kangyuan Medical ki te whakatuwhera i te maakete o EU me te whakanui i te ingoa o te waitohu ki te ao. I te wa ano, ka akiakihia e ia a Kangyuan Medical ki te whakahohonu tonu i tana whakahaere hanganga ture, te whakatere i nga mahi hangarau, me te whakatairanga i tana whakatakotoranga rautaki o te ao me nga paerewa teitei ake, na reira ka hangaia he raina whakamarumaru mo te hauora me te haumaru o nga kaihoko o te ao.
Te wa tuku: Mei-14-2025