Haiyan Kangyuan Medical Instrument Co., Ltd. manuia mauaina le European Union Medical Device Regulation 2017/745 (faatatau i le "MDR") CE tusi faamaonia i luga o Iulai 19, 2023, numera o le tusi faamaonia 6122159CE01, o le tusi faamaonia lautele o Urinary Catheters mo Fa'aoga nofofua (Foley2 auala), fa'apitoa fo'i fo'i silicone catheter catheter. 2 ala silicone foley catheter ma le tiemann pito ma le 3 auala silicone foley catheter ma le coude pito. I le taimi nei, ua pasia e Kangyuan Medical oloa MDR:

Endotracheal tubes mo le fa'aoga tasi;

Fa'amama Suction Catheters mo le Fa'aoga Tasi;

Mass Oxygen mo le Fa'aoga Tasi;

Nasal Oxygen Cannulas mo le fa'aoga tasi;

Guedel Airways mo le Fa'aoga Tasi;

Laryngeal Mask Airways;

Masi Fa'a'ese'ese mo Fa'aoga Ta'itasi;

Filifiliga Manava mo le Fa'aoga Tasi;

Si'osi'o Manava mo Fa'aoga Ta'itasi;

Urinary Catheters mo le Fa'aoga Tasi (Foley).

O le EU MDR certification o loʻo faʻaalia ai o oloa Kangyuan Medical e fetaui ma manaʻoga o le EU fou tulafono faatonutonu masini faafomai 2017/745, maua tulaga avanoa aupito lata mai o le maketi a le EU, ma e mafai ona faʻaauau pea ona faʻatau atu faaletulafono i maketi i fafo, faʻavaeina se faavae mautu mo le ulufale atu atili i le maketi a Europa ma faʻalauiloaina le faiga faʻavaomalo.