Xov Xwm Zoo!IVDR CECdaim ntawv pov thawj rau ACCUGENCE®Pcov khoom
Thaum Lub Kaum Hli Ntuj hnub tim 11, ACUGENCE Multi-Monitoring System ACCUGENCE® Multi-Monitoring Meter (ACCUGENCE Blood Glucose, Ketone thiab Uric Acid Analysis System, suav nrog Meter PM900, Blood Glucose Strips SM211, Blood Ketone Strips SM311, Uric Acid Strips SM411, thiab lwm yam)tau dhau daim ntawv pov thawj Class C ntawm IVDR.
Los ntawm kev tau txais daim ntawv pov thawj IVDR CE uas tau muab los ntawm TÜV SÜD, lub koom haum European Union tau ceeb toom, uas yog ib kauj ruam tseem ceeb thiab tseem ceeb hauv kev nce qib ntawm ACCUGENCE®, thiab yog ib qho kev tawg loj hauv txoj kev tshawb nrhiav kev lag luam txawv teb chaws ntawm e-LinkCare.
Txog IVDR
Txoj Cai Tswjfwm Kev Kho Mob Hauv Vitro Diagnostic (IVDR) ntawm EU, uas tau pib siv rau lub Tsib Hlis 25, 2017 thiab tau siv rau lub Tsib Hlis 26, 2022, muaj cov kev cai dav dua thiab nruj dua rau kev tshuaj xyuas kev siv tshuab, kev ntsuam xyuas kev kho mob, thiab kev saib xyuas kev lag luam ntawm cov khoom siv kho mob hauv vitro kom ntseeg tau tias muaj kev nyab xeeb, ua haujlwm tau zoo, thiab zoo ntawm cov khoom.
Raws li EU cov cai tswjfwm kev kuaj mob hauv vitro, kev tau txais daim ntawv pov thawj IVDR CE yog qhov tsim nyog rau kev nkag mus rau hauv kev lag luam EU, piv txwv li, cov khoom tau txais "visa" nkag mus rau hauv kev lag luam European.
Qhov tseeb tias peb cov khoom tuaj yeem tau txais daim ntawv pov thawj IVDR CE qhia tau tias peb qhov ACUGENCE®Lub Tshuab Saib Xyuas Ntau Yam tau ua tiav cov qauv siab ntawm kev ua lag luam European Union hauv cov khoom zoo, kev nyab xeeb thiab kev ua haujlwm zoo, nrog rau theem kev txawj ntse, thiabthiabqib kev tswj xyuas zoo tau mus txog cov qauv thoob ntiaj teb.
Lub sijhawm tshaj tawm: Lub Kaum Hli-25-2024

