The validity of our EC Certificate of HCG and LH test for self-testing has been extended to May 26, 2025.
May. 20, 2022
According to REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL AMENDING REGULATION (EU) 2017/746 AS REGARDS TRANSITIONAL PROVISIONS FOR CERTAIN IN VITRO DIAGNOSTIC MEDICAL DEVICES AND THE DEFERRED APPLICATION OF CONDITIONS FOR IN-HOUSE DEVICES, Devices with an EC certificate that was issued in accordance with Directive 98/79/EC may be placed on the market or put into service until 26 May 2025.
After the audit by TUV Rheinland, our EC Certificate for HCG Pregnancy Test and LH Ovluation Test has been extended from May 26 2024 to May 26 2025.
Our Accu-Tell® HCG Pregnancy Test and LH Ovulation Test for self-testing are certified to be placed on the market of OTC in EU member states.
