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Instruction manuals
CE marking
Many European directives stipulate that products must bear the CE marking (also incorrectly referred to as the "CE mark"). Anyone who affixes a CE marking to a product hereby declares to the authorities that the product- complies with all applicable European regulations and
- has undergone the prescribed conformity assessment procedures.
Green Spring (PDF)
Certificate
Getein (PDF)
Certificate
Date : 30.07.2021
Product: GETEIN Corona Test, 1er Nasal Laie
Discover the EC Certificate awarded to GETEIN Biotech, Inc. for their in vitro diagnostic medical devices, specifically the SARS-CoV-2 Antigen Test (Colloidal Gold). The certification, issued by the Polish Centre for Testing and Certification, confirms compliance with Directive 98/79/EC concerning in vitro diagnostic medical devices.
Clungene (PDF)
certificate
Date: 11.02.2022
Product: CLUNGENE Corona Test, 25er 3in1 Profi
earn more about the EC certificate awarded to Hangzhou Clongene Biotech Co., Ltd. for its in vitro diagnostic medical devices, in particular the COVID-19 antigen test. The certification, issued by the Polish Centre for Testing and Certification, confirms compliance with Directive 98/79/EC on in vitro diagnostic medical devices.
LONGSEE (PDF)
certificate
Datum: 01.02.2022
Product: LONGSEE Corona Test, 25er Nasal Profi
The 2019-nCoV Ag Rapid Detection Kit for self-testing by Guangdong Longsee Biomedical has obtained EU approval in accordance with Directive 98/79/EC. The certificate confirms compliance with the requirements of Annex III (Section 6) of the mentioned directive, as evidenced by the audit conducted by the Polish Centre for Testing and Certification (PCBC). The validity of the certificate extends from 01.02.2022 to 27.05.2025.
HIGHTOP (PDF)
Certificate
Date: 06.04.2022
Product: HIGHTOP Corona Test, 1er Nasal Laie
The EC certificate attests that the SARS-CoV-2 Antigen Rapid Test from Qingdao Hightop Biotech complies with the requirements of the EU directives for in vitro diagnostic medical devices. Valid from 13/08/2021 to 27/05/2024.
Test HOTGEN SLEEVE (PDF)
Certificate
Date: 04.08.2024
Product: HOTGEN SLEEVE Corona Test, 1er Nasal Laie
The CE Certificate confirms that the Coronavirus Antigen Tests by Beijing Hotgen Biotech comply with the requirements of Directive 98/79/EC for In Vitro Diagnostic Devices for Self-testing. Valid from 04.08.2021 to 26.05.2024.
fluorecare (PDF)
Certificate
Date:12.10.2022
Product: fluorecare Corona-, Influenza- & RSV-Test
CeCert announces the successful update of EC Certificates CeCert/091/W/E.1 and CeCert/092/W/E.2 for the SARS-CoV-2 self-tests fluorecare SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit and fluorecare SARS-CoV-2 Antigen Test Kit (Saliva) by Shenzhen Microprofit Biotech. The multilingual user instructions and labels for both devices, as well as the documents with the new additional brand 'SOLMIRA,' have been approved.
Product: fluorecare Corona-, Influenza- & RSV-Test
CeCert announces the successful update of EC Certificates CeCert/091/W/E.1 and CeCert/092/W/E.2 for the SARS-CoV-2 self-tests fluorecare SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit and fluorecare SARS-CoV-2 Antigen Test Kit (Saliva) by Shenzhen Microprofit Biotech. The multilingual user instructions and labels for both devices, as well as the documents with the new additional brand 'SOLMIRA,' have been approved.
PEKA FFP2 Schutzmaske (PDF)
Certificate
Date:15.12.2021
Product: PEKA FFP2 Schutzmaske, 50er
PEKA Medical GmbH, based in Velbert, Germany, receives the CE certificate (Registration Number 44 206 21151001) from TÜV NORD CERT GmbH for their Filtering Half Mask FFP2 NR 318. The respiratory masks comply with the essential safety requirements of EU Regulation 2016/425 for Personal Protective Equipment (PPE) Category III. The certificate is valid from 15.12.2021 to 14.12.2026.
PEKA FFP2 Schutzmaske (PDF)
Certificate
Date: 15.12.2021
Product: PEKA FFP2 Schutzmaske, 1er
Explore the certified FFP2 NR 318 respirator mask by PEKA Medical GmbH, tested according to EU Regulation 2016/425 and EN 149:2001+A1:2009. High-quality protection against COVID-19.
SAFECARE (PDF)
Certificate
Date: 23.9.2021
Product: SAFECARE Corona Test, 25er Nasal Profi
Explore the EC certified COVID-19 Antigen Rapid Test Kit (Swab) by Safecare Biotech. Complies with the requirements of Directive 98/79/EC, enabling safe self-testing for the coronavirus.
FLOWFLEX (PDF)
Certificate
Datum:14.5.2021
Product: FLOWFLEX Corona Test, 25er Nasal Profi
Learn about Acon Biotech's EC Design Examination Certificate under EU Directive 98/79/EC for in vitro diagnostic devices for self-testing. The certification includes various models, such as the Flowflex SARS-CoV-2 Antigen Rapid Test. For details and certificate validity, visit www.tuvsud.com.
CLUNGENE (PDF)
Certificate
Date:11.2.2022
Product: CLUNGENE Corona Test, 5er Nasal Laie
Learn about EC Certificate No. 1434-IVDD-017/2022 for in vitro diagnostic devices for self-testing, specifically the COVID-19 Antigen Rapid Test by Hangzhou Clongene Biotech. The certification under EU Directive 98/79/EC demonstrates compliance with the requirements of Annex III (Section 6). Valid from 11.02.2022 to 27.05.2025.
NEWGENE (PDF)
Certificate
Date:11.8.2021
Product: NEWGENE Corona Test 5er, Nasal - Laie
Learn about CE Certificate No. 1434-IVDD-449/2021 for in vitro diagnostic devices for self-testing, specifically the COVID-19 Antigen Detection Kit - Nasal Swab by New Gene Bioengineering. The certification under EU Directive 98/79/EC confirms compliance with the requirements of Annex III (Section 6). Valid from 11.08.2021 to 27.05.2024.
Product: NEWGENE Corona Test 5er, Nasal - Laie
Learn about CE Certificate No. 1434-IVDD-449/2021 for in vitro diagnostic devices for self-testing, specifically the COVID-19 Antigen Detection Kit - Nasal Swab by New Gene Bioengineering. The certification under EU Directive 98/79/EC confirms compliance with the requirements of Annex III (Section 6). Valid from 11.08.2021 to 27.05.2024.
van Laack Infektionsschutzkittel (PDF)
Certificate
Date:15.07.2025
Product: van Laack Infektionsschutzkittel
Learn about the EU Type Examination Certificate No. IFA 2001099 dated 16.07.2020 from the Institute for Occupational Safety and Health of the German Social Accident Insurance (IFA) for protective clothing by van Laack. This certification according to DIN EN 13034 and DIN EN 14126 confirms compliance with the requirements for protective clothing against liquid chemicals and infectious agents. Valid until 15.07.2025.
EP Maske
Certificate
Date: 30.09.2021
Product: EP Maske für Kinder CE, 6er
Find out more about the OEKO-TEX® certificate no. 16.HBG.89637, which authorises Extrapack OOD from Bulgaria to use the OEKO-TEX® STANDARD 100 trademark. The certification is based on test report 20.0.25476 and confirms that the non-woven fabrics made of 100% polypropylene in white, beige, light blue and black meet the human-ecological requirements of STANDARD 100 by OEKO-TEX®, especially for baby products. Valid until 30/09/2021.
RIGHTSIGN (PDF)
Certificate
Date: 01.09.2021
Product: RIGHTSIGN Corona Test, 1er Nasal Laie, 1 Karton = 500 Tests
Learn about EC Certificate No. 1434-IVDD-455/2021, granting Hangzhou Biotest Biotech Co., Ltd. approval for in vitro diagnostic medical self-tests for COVID-19 Antigen Rapid Tests. The list of covered medical devices is provided in Annex 1. Valid from 01.09.2021 to 27.05.2024.
DEEPBLUE (PDF)
Certificate
Date: 30.03.2022
Product: DEEPBLUE Corona Test 1er Speichel Laie
Learn about EC Certificate No. 1434-IVDD-055/2022, granted to Anhui Deepblue Medical Technology Co., Ltd. for in vitro diagnostic self-tests for COVID-19 Antigen Test (SARS-COV-2). The certification is valid from 30.03.2022 to 27.05.2025.
HYGISUN (PDF)
Certificate
Date: 04.09.2020
Product: HYGISUN Corona Test, 1er Speichel Laie
Explore the Declaration of Conformity according to Directive 98/79/EC for In Vitro Diagnostic Medical Devices (IVDD) of the Rapid COVID-19 Antigen Test (Colloidal Gold) by Anbio (Xiamen) Biotechnology Co., Ltd. The manufacturer affirms compliance with relevant standards and commits to a documented post-production monitoring process.
SINGCLEAN (PDF)
Certificate
Date: 22.09.2021
Product: SINGCLEAN Corona Test 5er, Nasal - Laie
Erfahren Sie mehr über das Zertifikat (EC Certificate No. 1434-IVDD-459/2021) für das COVID-19-Testkit (Colloidal Gold Method) von Hangzhou Singclean Medical Products. Das in vitro diagnostische Medizinprodukt für Selbsttests entspricht den Anforderungen der Richtlinie 98/79/EG und ist gemäß polnischem Recht zertifiziert.
LEPU NASOCHECK COMFORT (PDF)
Certificate
Date:17.04.2019
Product: LEPU NASOCHECK COMFORT Corona Test, 1er Nasal Laie
Learn more about the Quality Management Certificate issued by TÜV Rheinland LGA Products GmbH for Beijing Lepu Medical Technology. The certificate confirms compliance with the requirements of EN ISO 13485:2016 and is valid until February 12, 2022.
Chil Comfortcheck (PDF)
Certificate
Date: 28.04.2022
Product: Chil Comfortcheck, 1er Nasal - Laie
Learn more about the EC Design-Examination Certificate issued by Notified Body 1023 for the Covid-19 Antigen Rapid Test by manufacturer CHIL Tıbbi Malzeme Sanayi ve Ticaret Limited Şirketi. The certificate confirms compliance with the requirements of Directive 98/79/EC for in vitro diagnostic medical devices.
WIZBIOTECH (PDF)
Certificate
Date: 22.11.2021
Product: WIZBIOTECH Corona Test 1er, Nasal - Laie
Erfahren Sie mehr über das EC Design-Examination Certificate, ausgestellt vom Polish Centre for Testing and Certification, für den SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) von Xiamen Wiz Biotech. Das Zertifikat bestätigt die Konformität mit den Anforderungen der Richtlinie 98/79/EG für in vitro diagnostische Medizinprodukte.