Haiyan Kangyuan Medical Ntsuas Co., Ltd. tau ua tiav tau txais EU cov cuab yeej kho mob cov cai (EU 2017/745, hu ua "MDR") daim ntawv pov thawj thaum Lub Ob Hlis 1, 2023, daim ntawv pov thawj tus lej yog 6122159CE01, thiab cov peev txheej ntawm cov ntawv pov thawj suav nrog Endotracheal Tubes rau Kev Siv Ib Leeg, Sterile Suction Catheter rau Kev Siv Ib Leeg, Oxygen Qhov ncauj qhov ntswg rau Kev Siv Ib Leeg, Nasal Oxygen Cannulas rau Kev Siv Ib Leeg, Guedel Airways rau Kev Siv Ib Leeg, Laryngeal Mask Airways, Tshuaj Txhuam Hniav Qhov ncauj qhov ntswg rau Kev Siv Ib Leeg, Cov lim dej ua pa rau Kev Siv Ib Leeg, Kev Siv Hluav Taws Xob rau Kev Siv Ib Leeg.

Nws tau tshaj tawm tias EU Kev Tswj Xyuas Kev Kho Mob MDR (EU 2017/745) tau pib siv rau lub Tsib Hlis 25, 2017, hloov kho Cov Ntawv Qhia Txog Kev Kho Mob MDD (93/42 / EEC) thiab Active Implantable Medical Instrument Directive AIMDD (90/385 /EEC), txhawm rau tsim kom muaj kev tswj hwm niaj hnub thiab nruj dua los tiv thaiv kev noj qab haus huv thiab kev nyab xeeb ntawm pej xeem thiab cov neeg mob zoo dua. Ntawm lawv, MDR tau muab cov kev cai nruj dua rau cov tuam txhab kev kho mob raws li kev tswj hwm kev pheej hmoo ntawm cov khoom lag luam, kev ua tau zoo ntawm cov khoom lag luam thiab cov qauv kev nyab xeeb, kev soj ntsuam kev soj ntsuam, thiab kev ceeb toom tom qab kev lag luam thiab kev saib xyuas. Piv nrog rau MDD cov lus qhia, kev tswj hwm MDR muaj kev saib xyuas zoo dua, kev pov thawj nyuaj dua, thiab them nyiaj ntau dua rau kev nyab xeeb thiab kev ua tau zoo ntawm cov khoom.

Kangyuan Kev Kho Mob tau ua tiav tau txais daim ntawv pov thawj MDR lub sijhawm no, uas ua pov thawj tag nrho tias Kangyuan cov khoom tau mus txog kev lees paub ntawm EU thiab thoob ntiaj teb kev lag luam nyob rau hauv cov nqe lus ntawm kev tswj ntau lawm, kev ruaj ntseg zoo thiab kev tswj hwm kev pheej hmoo.

Rau Kangyuan Kev Kho Mob, uas tau koom nrog kev lag luam nyob sab Europe ntau tshaj kaum xyoo, qhov tau txais daim ntawv pov thawj MDR yog qhov tseem ceeb. , Latin America thiab lwm lub lag luam muab kev txhawb zog.