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, nọmba akwụkwọ 6122159CE01, ogo asambodo bụ Urinary Catheters maka otu ojiji ( Foley), Kpọtụrụ gụnyere ụzọ abụọ silicone foley catheter, 3 ụzọ silicone foley catheter, ụzọ abụọ 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 ma nwee 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 nhazi ụwa.
Oge nzipu: Jul-26-2023