Haiyan Kangyuan Medical Akụrụngwa Co., Ltd. nwetara akwụkwọ ikike nke EU Medical Instruments ụkpụrụ (EU 2017/745, nke a na-akpọ "MDR") na February 1, 2023, nọmba asambodo bụ 6122159CE01, na ogo nke asambodo gụnyere Endotracheal tubes maka otu ojiji, Ihe nkpuchi sterile maka iji otu, oxygen masks maka otu ojiji, imi oxygen Cannulas maka otu ojiji, Guedel Airways maka otu ojiji, Laryngeal Mask Airways, Anesthesia Masks maka otu ojiji, ihe nzacha iku ume maka otu ojiji, sekit iku ume maka otu ojiji.
A na-akọ na EU Medical Instrument Regulation MDR (EU 2017/745) malitere na Mee 25, 2017, dochie Medical Instrument Directive MDD (93/42/EEC) na AIMDD AIMDD (90/385) /EEC), na-achọ iguzobe usoro nhazi nke ọgbara ọhụrụ na nke siri ike iji chebe ahụike na nchekwa nke ọha na eze na ndị ọrịa. N'ime ha, MDR ewepụtala ihe ndị siri ike maka ndị na-emepụta ngwa ahụike n'ihe gbasara njikwa ihe egwu ngwaahịa, arụmọrụ ngwaahịa na ụkpụrụ nchekwa, nyocha ụlọ ọgwụ, na njikere na nleba anya mgbe ahịa gasịrị. Tụnyere ntuziaka MDD, MDR na-achịkwa nwere nlekọta siri ike, asambodo siri ike karị, ma na-etinyekwu uche na nchekwa na ịdị irè nke ngwaahịa.
Kangyuan Medical enwetala akwụkwọ ikike MDR nke ọma n'oge a, nke gosipụtara n'ụzọ zuru ezu na ngwaahịa Kangyuan erutela nnabata nke EU na ahịa mba ụwa n'ihe gbasara njikwa mmepụta, mmesi obi ike na njikwa ihe egwu.
Maka Kangyuan Medical, nke na-etinye aka na ahịa Europe ihe karịrị afọ iri, inweta akwụkwọ MDR bụ ihe dị ịrịba ama. , Latin America na ahịa ndị ọzọ nyere nkwado siri ike.
Oge nzipu: Feb-06-2023