War Wanaagsan!CE-da IVDRCShahaadada ACCUGENCE®Palaabada
11 Oktoobar, ACCUGENCE Multi-Monitoring System ACCUGENCE® Multi-Monitoring Meter (ACCUGENCE Blood Glucose, Ketone and Uric Acid Analysis System, oo ay ku jiraan Meter PM900, Blood Glucose Xariiqyada SM211, Blood Ketone Xariiqyada SM311, Blood Acid Xariiqyada SM411, iwm.)waxay ka gudubtay shahaadada Heerka C ee IVDR.
Iyadoo la helayo shahaadada CE ee IVDR oo ay bixisay TÜV SÜD, hay'adda Midowga Yurub ee la ogeysiiyay, taas oo ah tallaabo muhiim ah oo muhiim ah oo ku saabsan horumarka ACCUGENCE®, waxayna calaamad u tahay horumar weyn oo ku yimid geeddi-socodka sahaminta suuqa dibadda ee e-LinkCare.
Ku saabsan IVDR
Xeerka Qalabka Caafimaadka ee Midowga Yurub ee In Vitro Diagnostic (IVDR), kaas oo dhaqan galay Maajo 25, 2017 lana dhaqan geliyay Maajo 26, 2022, wuxuu leeyahay shuruudo dhammaystiran oo adag oo ku saabsan dib u eegista farsamada, qiimeynta kiliinikada, iyo kormeerka suuqa ee aaladaha caafimaadka ee lagu ogaanayo in vitro si loo hubiyo badbaadada, waxtarka, iyo tayada alaabada.
Sida ku xusan xeerarka qalabka caafimaadka ee baaritaanka jirka ee EU-da, helitaanka shahaadada CE ee IVDR waa shuruud lagama maarmaan u ah helitaanka badeecada suuqa EU, tusaale ahaan, badeecadu waxay heshay "fiisaha" si ay u gasho suuqa Yurub.
Xaqiiqda ah in alaabtayadu ay heli karaan shahaadada CE ee IVDR waxay muujinaysaa in DACWADdeennu ay tahay®Nidaamka Kormeerka Badan wuxuu buuxiyay shuruudaha heerka sare ah ee suuqa Midowga Yurub marka la eego tayada badeecadaha, badbaadada iyo waxtarka, iyo sidoo kale heerka farsamada, iyosidoo kaleHeerka xakamaynta tayada ayaa gaaray heerarka caalamiga ah.
Waqtiga boostada: Oktoobar-25-2024

