Following the Announcement from 31/5/2021 regarding the Coronavirus Detection Tests, the AEO for the information of the public, publishes the updated list of self-diagnostic tests that have received CE Certificate from a Notified Organization and have been notified in the I / O AEO Register.
List of Self-Diagnostic Tests, notified in the Register of I / P EOF.
1. “Rapid SARS-CoV-2 Antigen Test Card” (ref.:1N40C5-2, ref.:1N40C5-4, ref.:1N40C5-6) manufactured 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), manufactured by ACON BIOTECH (HANGZHOU) CO., LTD, (China), with an authorized representative for E .Ε. 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), manufactured by 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. “SGTi-flex COVID-19Ag” (ref .: CAGT001E0) of the manufacturer SUGENTECH INC. (S. Korea), with an authorized representative for the EU. the company MT PROMEDT CONSULTING GMBH (Germany) and CE certificate from the Notified Organization TÜV SÜD Product Service GmbH, No. 0123, with expiration date 26/5/2024.
5. “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.
6. “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.
7. “COVID-19 Antigen Rapid Test (Oral Fluid)” (ref .: ICOV-802H) of the manufacturer HANGZHOU ALLTEST BIOTECH CO. LTD (China), with an authorized representative for the EU the company MEDNET GMBH (Germany) and CE certificate from the Notified Organization POLSKIE CENTRUM BADAN I CERTYFIKACJI SA, No. 1434, with expiration date 27/5/2024.
8. “SARS-CoV-2 Antigen Rapid Test (Nasal Swab)” (ref: INCP-502H) of the manufacturer HANGZHOU ALLTEST BIOTECH CO. LTD (China), with an authorized representative for the EU the company MEDNET GMBH (Germany) and CE certificate from the Notified Organization POLSKIE CENTRUM BADAN I CERTYFIKACJI SA, No. 1434, with expiration date 27/5/2024.
9. “Rapid COVID-19 Antigen Self-Test” (GCCOV-502a-H5) of the manufacturer HEALGEN SCIENTIFIC LIMITED LIABILITY COMPANY (China), 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, No.0123, expiring on 26/5/2024.
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