Nkhani Yabwino！IVDR CECkutsimikizira kwa ACCUGENCE®Pzinthu  

Pa 11 Okutobala, ACCUGENCE Multi-Monitoring System ACCUGENCE® Multi-Monitoring Meter (ACCUGENCE Blood Glucose, Ketone ndi Uric Acid Analysis System, kuphatikiza Meter PM900, Blood Glucose Strips SM211, Blood Ketone Strips SM311, Uric Acid Strips SM411, ndi zina zotero)adapambana satifiketi ya Class C ya IVDR.

Mwa kupeza satifiketi ya IVDR CE yoperekedwa ndi TÜV SÜD, bungwe lodziwitsidwa la European Union, lomwe ndi gawo lofunika komanso lofunika kwambiri pakupita patsogolo kwa ACCUGENCE®, ndipo likuwonetsa kupita patsogolo kwakukulu pakufufuza msika wakunja wa e-LinkCare.

Zokhudza IVDR

Lamulo la EU In Vitro Diagnostic Medical Devices Regulation (IVDR), lomwe linayamba kugwira ntchito pa Meyi 25, 2017 ndipo linayamba kugwira ntchito pa Meyi 26, 2022, lili ndi zofunikira zambiri komanso zolimba pakuwunikanso ukadaulo, kuwunika zachipatala, komanso kuyang'anira msika wa zida zamankhwala zodziwira matenda m'thupi kuti zitsimikizire chitetezo, kugwira ntchito bwino, komanso mtundu wa zinthuzo.

Malinga ndi malamulo a EU okhudza chipangizo chamankhwala chodziwira matenda m'thupi, kupeza satifiketi ya IVDR CE ndikofunikira kuti malonda alowe mumsika wa EU, mwachitsanzo, malondawo apeza "visa" yolowera mumsika wa ku Europe.

Mfundo yakuti zinthu zathu zimatha kulandira satifiketi ya IVDR CE ikuwonetsa kuti ACCUGENCE yathu®Dongosolo Loyang'anira Zambiri lakwaniritsa zofunikira zapamwamba pamsika wa European Union pankhani ya mtundu wa malonda, chitetezo ndi magwiridwe antchito, komanso mulingo waukadaulo, ndikomansomulingo wowongolera khalidwe wafika pa miyezo yapadziko lonse lapansi.