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 whānuitanga o te tiwhikete he Urinary Catheters mo te Whakamahi Kotahi (Foley2), ara te silicone foeley catheter. 2 ara silicone foley catheter ki tiemann matamata me 3 ara silicone foley catheter ki coude matamata. 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 EU 2017/745, kei a raatau nga tikanga whakauru hou o te maakete EU, a ka taea tonu te hoko ture i nga maakete o tawahi e tika ana, me te whakatakoto i te turanga pakari mo te uru atu ki te maakete a te Pakeha me te whakatairanga i te tukanga ao.