Jei Daniel (JD) Biotech Corp is the manufacturer of in vitro diagnostic medical devices under Regulation (EU) 2017/746 (IVDR). A formal application has been submitted to our Notified Body , and a written agreement in accordance with Annex VII, Section 4.3 of IVDR has been signed. As the legal manufacturer, Jei Daniel (JD) Biotech Corp is responsible for ensuring compliance with IVDR requirements and maintaining the conformity of its IVD devices throughout their lifecycle, under the transitional provisions of Regulation (EU) 2024/1860.
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