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COVID-19 Antigen Rapid Test CE Certification

COVID-19 Antigen Rapid Test CE Certification

COVID-19 Antigen Rapid Test CE Certification

Product catalog summary
European Authorized Representative: CMC Medical Devices & Drugs S.L. is confirmed as the European Authorized Representative for Taizhou Sun Trine Biotechnology Co., Ltd, located at NO.420 Jianggao Road, Medical High-tech Zone, Taizhou City, Jiangsu, China.
Certificate Validity: The certificate remains valid until changes occur in the EC REP agreement, manufacturing conditions, quality system, or relevant legislation. Its validity is also conditioned by positive results from periodic surveillance audits.
Product Liability: The manufacturer holds product liability in accordance with applicable directives and standards. After fulfilling relevant EU legislation requirements, the manufacturer must affix the CE marking to all mentioned models of the medical device.
Compliance: The products comply with the essential requirements of the Council Directive 98/79/EEC for in vitro diagnostics, as amended.
Registration: The products listed in Annex I were registered with the Spanish Ministry of Health under number RPS/2689/2020.
Issued Date: 23/11/2020
Validity: Until 22/11/2021
Annex I - Medical Device Products: Viral antigen detection reagent (colloidal gold).
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Catalog excerpts

COVID-19 Antigen Rapid Test CE Certification-1

CMC MEDICAL DEVICES & DRUGS SL NO. CMC/CE/2020/23112020.10 CONFIRMED THAT CMC MEDICAL DEVICES & DRUGS S.L. Is the European Authorized Representative of Tai zhou Sun Trine Biotechnology Co.,Ltd NO.420 Jianggao Road Medical High-tech Zone Taizhou City, 225300, Jiangsu, China The certificate remains valid until the expiration agreement of EC REP, manufacturing conditions, the quality system or relevant legislation are changed. The validity is conditioned by positive results of periodic surveillance audits. The product liability rests with the manufacturer in accordance with applicable directive and standard, after fulfilling of the relevant EU legislation requirements, the manufacturer shall affix relevant CE marking to all above mentioned models of the medical device. Complies with the applicable essential requirements of the council directive 98/79/EEC in vitro diagnostics as amended. The products in Annex I was registered in Spanish MOH with number RPS/2689/2020 Valid until: 22/11/2021 Authorized Signatory CMC Medical Devices & Drugs SL

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COVID-19 Antigen Rapid Test CE Certification-2

ANNEX I Medical Device Products Viral antigen detection reagent (colloidal gold)

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.