Haiyan Kangyuan Medical Instrument Co., Ltd. nwetara nke ọma European Union Medical Device Regulation 2017/745 (nke a na-akpọ "MDR") CE asambodo na July 19, 2023, akwụkwọ nọmba 6122159CE01, na asambodo akporo bụ Urinary Catheters maka Single Use (Foley ụzọ silicone), Specifically ụzọ silicon. foley catheter, 2 ụzọ silicone foley catheter nwere tiemann tip na ụzọ atọ silicone foley catheter nwere ọnụ ọnụ coude. Ugbu a, Kangyuan Medical agafeela ngwaahịa MDR:

Endotracheal tubes maka otu ojiji;

Ihe kateeta mmiri na-amị amị maka otu ojiji;

Ihe mkpuchi oxygen maka otu ojiji;

Cannulas oxygen imi maka otu ojiji;

Guedel Airways maka otu ojiji;

Laryngeal mkpuchi ụgbọ elu;

Masks Anesthesia maka otu ojiji;

Ihe nzacha iku ume maka otu ojiji;

Sekit iku ume maka otu ojiji;

Ọkpụkpụ Urinary maka otu ojiji (Foley).

Asambodo EU MDR na-egosi na ngwaahịa ahụike Kangyuan na-emezu ihe achọrọ nke iwu ngwaọrụ ahụike EU kacha ọhụrụ 2017/745, nwere ọnọdụ ohere ọhụụ nke ahịa EU, yana enwere ike ịga n'ihu na-ere ya n'ụzọ iwu na ahịa mba ofesi dị mkpa, na-atọ ntọala siri ike maka ịbanye n'ahịa Europe na ịkwalite usoro mba ụwa.