Haiyan Kangyuan Medical Instrument Co., Ltd. i pai te whiwhi i te European Union Medical Device Regulation 2017/745 (e kiia ana ko "MDR") te tiwhikete CE i te Hōngongoi 19, 2023, te nama tiwhikete 6122159CE01, ko te waahanga tohu ko te Urinary Catheters mo te Whakamahi Kotahi ( Foley), Kei roto motuhake te 2 ara silicone foley catheter, 3 ara silicone foley catheter, 2 ara silicone foley catheter me te matamata tiemann me te 3 ara silicone foley catheter me te matamata coude. I tenei wa, kua paahitia e Kangyuan Medical nga hua MDR:

Ngongo Endotracheal mo te Whakamahinga Kotahi;

Nga Kaitao Momo Hangarite mo te Whakamahinga Kotahi;

Ko nga Matapihi Oxygen mo te Whakamahinga Kotahi;

Nasal Oxygen Cannulas mo te Whakamahi Kotahi;

Guedel Airways mo te Whakamahi Kotahi;

Laryngeal Mask Airways;

Ko nga Maama Whakamaori mo te Whakamahinga Kotahi;

Tātari Manawa mo te Whakamahi Kotahi;

Takiwa Manawa mo te Whakamahi Kotahi;

Ko nga Waea Mimi mo te Whakamahi Kotahi (Foley).

Ko te tiwhikete EU MDR e whakaatu ana ko nga hua rongoa Kangyuan e tutuki ana i nga whakaritenga o te ture taputapu rongoa hou a te EU 2017/745, kei a raatau nga tikanga uru hou o te maakete EU, ka taea tonu te hoko i te ture ki nga maakete o tawahi e tika ana, me te whakatakoto i te turanga pakari mo ka uru atu ano ki te maakete a te Pakeha me te whakatairanga i te kaupapa o te ao.