The updated list of approved self tests and rapid tests for coronavirus was published by EOF (National Medicines Agency). It is pointed out that they have received CE Certificate from a Notified Organization and have been notified in the I / P EOF Register.
1. “Rapid SARS-CoV-2 Antigen Test Card” (ref.:1N40C5-2, ref.:1N40C5-4, ref.:1N40C5-6) by Xiamen Boson Biotech Co., Ltd., (China) , with an authorized representative for the EU the company LOTUS NL BV (Netherlands) and CE certificate from the Notified Organization TÜV SÜD Product Service GmbH, No. 0123, with expiration date 26/5/2022.
2. “FlowFlex SARS-CoV-2 Antigen Rapid Test (Self-Testing)” (ref .: L031-118M5, L031- 118P5, L031-118R5), manufactured by ACON BIOTECH (HANGZHOU) CO., LTD, (China ), with an authorized representative for the EU the company MEDNET GMBH (Germany) and CE certificate from the Notified Organization TÜV SÜD Product Service GmbH, No. 0123, with expiration date 26/5/2024.
3. “SARS-CoV-2 Antigen Self Test Nasal 5 Tests” (ref .: 9901-NCOV-06G), of the manufacturer SD BIOSENSOR, INC (S. Korea), with an authorized representative for the EU. the company MT PROMEDT (Germany) and CE certificate from the Notified Organization TÜV SÜD Product Service GmbH, No. 0123, with expiration date 26/5/2024.
4. “Wondfo SARS-CoV-2 Antigen Test (Lateral Flow Method)” (ref .: W634P0024) of the manufacturer GUANGZHOU WONDFO BIOTECH CO LTD (China), with an authorized representative for the EU. QARAD BVBA (Belgium) and CE certificate from the Notified Organization TÜV SÜD Product Service GmbH, No. 0123, with expiration date 26/5/2024.
5. “COVID-19-CHECK-1 ANTIGEN” (ref .: 200074-4) of the manufacturer VEDALAB (France), and CE certificate from the Notified Body MDC MEDICAL DEVICE CERTIFICATION GMBH, No.0483, with expiration date 27 / 5/2024.
6. “Rapid COVID-19 Antigen Self-Test” (GCCOV-502a-H5) of the manufacturer HEALGEN SCIENTIFIC LIMITED LIABILITY COMPANY (USA), with an authorized representative for the EU. the company SHANGHAI INTERNATIONAL HOLDING CORP. GMBH (EUROPE) (Germany) and CE certificate from the Notified Organization TÜV SÜD Product Service GmbH Zertifizierstellen (0123), expiring on 26/5/2024.
7. “COVID – 19 Test Kit (Colloidal Gold Method)” of the manufacturer HANGZHOU SINGCLEAN MEDICAL PRODUCTS CO LTD (China), with an authorized representative for the EU. the company SUNGO EUROPE BV (Netherlands) and CE certificate from the Notified Organization POLSKIE CENTRUM BADAN I CERTYFIKACJI SA, No. 1434, with expiration date 27/5/2024.
8. “COVID-19 Antigen Detection Kit (Colloidal Gold) Nasal Swab” (ref .: LCV03, LCV035, LCV03I) of the manufacturer ZHUHAI LITUO BIOTECHNOLOGY CO., LTD. (China), with an authorized representative for the EU the company CMC MEDICAL DEVICES & DRUGS SL (Spain) and CE certificate from the Notified Body POLSKIE CENTRUM BADAN I CERTYFIKACJI SA, No. 1434, with expiration date 27/5/2024.
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