• DEEPBLUE Medical Technology Co.,Ltd successfully passed the audit of MDSAP quality management system

    News Nov 30, 2023

    DEEPBLUE Medical Technology Co.,Ltd successfully passed the audit of MDSAP quality management system
    On 28th November 2023, Anhui DEEPBLUE Medical Technology Co.,Ltd successfully passed the audit of MDSAP(Medical Device Single Audit Program) quality management system, and was awarded the certificate of MDSAP quality management system authentication (Certificate No.: No.QS6 003706 0004 (Certificate No. QS6 003706 0004 Rev.00). This quality management system certification brings DEEPBLUE more convenient access to the global market, which is conducive to improving product quality, safety, competitiveness and international market recognition, which will have a positive impact on DEEPBLUE's future development of the international market.
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  • Authoritative Certification | DEEPBLUE Medical obtained the

    News Aug 31, 2022

    Authoritative Certification | DEEPBLUE Medical obtained the "Certificate of Export Commodity Brand"
    Recently, Anhui Deepblue Medical Technology Co., Ltd. (hereinafter referred to as DEEPBLUE) approved the approval of the China Council for the Promotion of International Trade CCPIT (hereinafter referred to as: CCPIT) evaluation, obtained the "Certificate of Export Commodity Brand", which is the national authority of DEEPBLUE export ability highly affirmed, is the future of the work of DEEPBLUE to further expand the overseas market, improve the international brand awareness and competitiveness of the international market. With the progress of social economy, brand building is particularly important in the process of enterprise development. Brand is an intangible asset of an enterprise, which reflects the economic strength, development level and overall image of an enterprise to a certain extent, and is an advantageous weapon for an enterprise in the fierce market competition. Vigorously implementing the brand strategy can not only help enterprises to establish a good corporate image and reputation, improve the trust of customers, but also help enterprises continue to expand the market, in the competition to occupy the advantage. In recent years, DEEPBLUE has accelerated the pace of participating in global competition and created a series of brands with good reputation, which is not only related to the development of enterprises, but also a strong embodiment of enhancing the comprehensive competitiveness of DEEPBLUE. In 2017, the establishment of the International Department of DEEPBLUE marked the formal entry of DEEPBLUE into the international market. In the process of hard struggle from weak to strong, from point to surface, DEEPBLUE relies on innovative technical strength, timely delivery ability, continuous improvement of after-sales service network and continuous optimization and adjustment of brand layout, adding bricks and tiles to "Deepblue Manufacturing" bit by bit, demonstrating the brand strength of DEEPBLUE. The certificate of export commodity brand is also a "cognitive method" for DEEPBLUE, which enables DEEPBLUE to have an in-depth understanding of the current situation and shortcomings of its own development, point out the direction for further improvement and development of the enterprise, and boost the implementation of the "going out" strategy. In the future, DEEPBLUE will be combined with the Suggestions for improvement of CCPIT, further implement the strategy of brand, comprehensive brand building layout, at the same time uphold the beginner's mind, give full play to accumulate and enterprise innovation advantage, strengthen intellectual property rights achievements transformation and product iteration, perfect the system of the intellectual property rights (ipr) protection, increasing foreign propaganda and comprehensive maintenance brand awareness and reputation, DEEPBLUE will further expand the international market of products and make greater contribution to building a carrier for the health industry.
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  • DEEPBLUE Medical COVID-19 Antigen Self-test Saliva Reagent completed the registration of CTDA in the UK

    News Dec 06, 2022

    DEEPBLUE Medical COVID-19 Antigen Self-test Saliva Reagent completed the registration of CTDA in the UK
    On December 1st, 2022, DEEPBLUE Medical COVID-19 Antigen Self-test Saliva Reagent completed the registration of CTDA in the UK, and was approved to be listed in the UK as an antigen saliva self-test product. The certificate is valid for 5 years. DEEPBLUE Medical is the first enterprise in China to obtain saliva self-test CTDA. With rich industry experience and professional independent research and development ability, DEEPBLUE Medical actively expands overseas registration while deeply studying international industry regulations, product certification regulations and commercial systems of various countries. At present, a series of products independently developed and produced by DEEPBLUE Medical have successively participated in the bidding activities of governments all over the world, and have been listed and sold in hospitals, supermarkets and pharmacies in several overseas countries, thus establishing a stable and reliable regional network, and making more DEEPBLUE Medical products go global. The successful achievement of CTDA certification of saliva product, an antigen self-test reagent in COVID-19, will help DEEPBLUE Medical to further expand overseas product sales channels and enhance the influence of its own brand, creating favorable conditions and laying a solid foundation for more independent brand products to enter the international market in the future. DEEPBLUE Medical will take this certification as an opportunity to further improve the quality of professional products, enhance the comprehensive strength of DEEPBLUE Medical with high-level international technical means, and provide strong support for the development of POCT industry.
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  • DEEPBLUE COVID-19 antigen detection kit

    News Mar 15, 2021

    DEEPBLUE COVID-19 antigen detection kit "appears" on German TV
    The novel coronavirus antigen detection kit independently developed by Anhui Deep Blue Medical Technology Co., Ltd. passed the 3B stage test of the British government in 2020, and successfully obtained the British MHRA registration certificate. Good news came from Germany in 2021. At the beginning of March, the novel coronavirus antigen detection kit passed the evaluation of the German laboratory PEI. German TV stations simultaneously explained the steps of using the dark blue antigen detection kit to the public in detail, no laboratory equipment or professional Laboratory personnel or medical personnel operate. After obtaining special permission from Germany, the public can take samples and test at home. The results will be obtained within 15-20 minutes, and the test results will be used to determine whether they are infected with the new coronavirus. The Deepblue Novel Coronavirus Antigen Detection Kit is simple to operate, fast to detect, and easy to sample. Both front nasal swabs and saliva can be detected. Report link: https://v.qq.com/x/page/x3233f39lbk.html
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  • DEEPBLUE Coronavirus (COVID-19) antigen detection reagent-saliva has passed CE1434 certification, and its comprehensive strength has been internationally recognized

    News Nov 19, 2021

    DEEPBLUE Coronavirus (COVID-19) antigen detection reagent-saliva has passed CE1434 certification, and its comprehensive strength has been internationally recognized
    Anhui Deepblue Medical Technology Co., Ltd. (hereinafter referred to as "Deepblue Medical") has made great achievements in expanding the market recently. Its domestic business is booming, and its foreign trade business is constantly breaking through. In order to better serve the EU market, Deepblue Medical has been deeply engaged in the field of technology research and development. After unremitting efforts, the self-developed novel coronavirus (COVID-19) antigen detection reagent-saliva has successfully obtained the CE1434 certificate on November 10, 2021. Deepblue medical novel coronavirus (COVID-19) antigen detection reagent-saliva successfully obtained the CE1434 certificate. So far, Deepblue Medical has passed CE1434 certification for 3 types of novel coronavirus (COVID-19) products, mainly including novel coronavirus (COVID-19) neutralizing antibody (double antigen sandwich) detection reagents, novel coronavirus (COVID-19) antigen detection reagents -Anterior nose, novel coronavirus (COVID-19) antigen detection reagents-saliva, so far, Deepblue Medical is one of the only IVD companies in China that have obtained three certificates at the same time. Deepblue Medical has a wealth of novel coronavirus products and detection solutions. Help global epidemic prevention and control. Deepblue Medical Novel Coronavirus (COVID-19) Antigen Saliva Detection Reagent can quickly detect whether saliva contains nocel coronavirus through saliva samples collected from individuals. It is a very suitable product for personal and family self-testing. It has the following main features Features: Convenient sampling Convenient and fast The results are accurate Since the early stage of the outbreak of the novel coronavirus, Deepblue Medical has integrated its technical strength, and its self-developed series of novel coronavirus (COVID-19) antigen detection reagents have been verified by multiple authoritative institutions: through the British Phase 3B test, the German BfarM special authorization, the Netherlands MINVWS special authorization, etc. The CE1434 certification of the series of novel coronavirus products not only reflects that the product's excellent performance and good user experience have been fully recognized, and meets the needs of the international market, it is also a favorable evidence for Deepblue Medical's influence in the IVD industry, international customer recognition, and international competitiveness. . Deepblue Medical Novel Coronavirus (COVID-19) Antigen Detection Reagent - Saliva Detection Reagent Relying on professional scientific research and innovation strength, Deepblue Medical has independently developed novel coronavirus (COVID-19) antigen saliva detection reagents in a faster and more convenient way to meet the needs of individuals and families for self-testing, allowing more people to cut the infection chain faster , to prevent the risk of virus transmission. In addition, Deep Blue can also provide a full range of rapid detecti...
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  • DEEPBLUE Novel Coronavirus (COVID-19) Neutralizing Antibody (Double Antigen Sandwich) Detection Reagent was awarded CE 1434 Certificate

    News Oct 11, 2021

    DEEPBLUE Novel Coronavirus (COVID-19) Neutralizing Antibody (Double Antigen Sandwich) Detection Reagent was awarded CE 1434 Certificate
    On October 8, 2021, the novel coronavirus (COVID-19) neutralizing antibody (double antigen sandwich) detection reagent (colloidal gold method) independently developed by Anhui Deepblue Medical successfully obtained the CE1434 certificate, which meets the relevant EU requirements and market standards. Entry qualification. CE 1434 self-test certification is not only difficult, long-term, and strict, but also a test of comprehensive strength. In July 2021, DeepBlue Medical's novel coronavirus (COVID-19) antigen detection reagent obtained the CE1434 certificate, and the new coronavirus (COVID-19) neutralizing antibody (double-antigen sandwich) detection reagent obtained the CE1434 certificate. The strong recognition of the research and development technology of viral in vitro diagnostic reagents has far-reaching significance for the development of the international market and brand expansion. The novel coronavirus (COVID-19) neutralizing antibody (double-antigen sandwich) detection reagent independently developed by Anhui Deepblue Medical has obtained the CE1434 certificate, which can not only be freely sold in the 31 EU member states, but also bring more convenience to the global anti-epidemic. Check resources. The blessing of the CE1434 certificate also reflects the European market's recognition of the performance and user experience of DeepBlue Medical products, and it is also a high affirmation of the comprehensive strength of DeepBlue Medical. At present, most countries and regions in the world have gradually shifted from nucleic acid testing during the outbreak to neutralizing antibody testing to assess whether immunity is protected. The Deepblue Medical Novel Coronavirus (COVID-19) Neutralizing Antibody (Double Antigen Sandwich) Detection Reagent can simply, quickly and effectively reflect the presence and level of neutralizing antibodies after vaccination, and play a guiding role in the need for booster vaccination. In the future, Deepblue Medical will continue to adhere to the vision of "based on the health industry, give full play to the advantages of science and technology, and build a health industry aircraft carrier", strive to develop better products, and contribute to the global epidemic prevention and control and the evaluation of the immune effect of vaccines!
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  • Statement

    News Oct 21, 2022

  • DEEPBLUE COVID-19 Antigen Test can detect Omicron variants  Evaluated by UCK Poland

    News Jun 08, 2022

    DEEPBLUE COVID-19 Antigen Test can detect Omicron variants Evaluated by UCK Poland
    DEEPBLUE COVID-19 Antigen Test can detect Omicron variants  Evaluated by UCK Poland Screenshot of the evaluation report Since the launch of the COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold), we have closely followed market changes and needs, and have always paid attention to the feedback of users and distributors after the product has been launched, and continuouslyvalidate our test with new variants. Recently we have completed the Clinical Evaluation on UCK Poland and the results indicates DEEPBLUE Antigen test is able to detect Omicron variants and the sensitivity is very high. Screenshot of the evaluation report
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  • DEEPBLUE's Monkeypox Test Kit have been registered in Germany and UK.

    News Oct 24, 2022

    DEEPBLUE's Monkeypox Test Kit have been registered in Germany and UK.
    The four products of Monkeypox Virus Antigen Test Kit (Colloidal Gold), Monkeypox Virus IgG/IgM Antibody Test kit (Colloidal Gold), Monkeypox Virus Nucleic Acid Test Kit (Isothermal Amplification- Real-time Fluorescence) and Monkeypox Virus Nucleic Acid Test Kit (PCR-Fluorescent Probe) self-developed by DEEPBLUE Medical have passed the registration in Germany and UK. DEEPBLUE Medical, established in February 2010, is a national high-tech enterprise focusing on the R&D, production and marketing of in vitro diagnostic reagentsIt has been awarded the honors of Anhui Export Brand Demonstration Enterprise, Anhui Trademark Brand Demonstration Enterprise, Hefei Brand Cultivation Enterprise, Hefei Specialized and New Enterprise, Hefei Enterprise Technology Center, Hefei Harmonious Labor Relations Demonstration Enterprise, and High-tech Zone Three-Eight Red Flag Collective, etc. DEEPBLUE Medical has obtained CE 0123, CE 1434 and UK MHRA certifications for many products; 118 registrations have been obtained in many countries; virus test products have passed clinical validation in Germany PEI, Spain, Poland UCK, Denmark, the United States and other countries, with product footprints in Europe, North America, South America, the Middle East, Southeast Asia and nearly 100 countries around the world. DEEPBLUE Medical will continue to pay attention to international public health events, uphold the mission of "customer satisfaction is our highest honor, employee satisfaction is our eternal goal, shareholder satisfaction is our greatest responsibility", is committed to play the role of rapid diagnostic products in disease surveillance, health warning, and constantly increase investment in research and develop more directional test products to contribute to the promotion of high-quality development of the IVD industry. Popular Science Monkeypox is a zoonotic virulent disease caused by monkeypox virus (MPXV). It is a double-stranded DNA virus belonging to the genus orthopoxvirus of the family Poxviridae, along with smallpox virus, vaccinia virus and cowpox virus. In the past 4 months, the monkeypox epidemic has spread to 105 countries and regions. WHO data show that as of September 19, 2022, countries have reported 61,753 laboratory-confirmed cases and 533 suspected cases, including 23 deaths.
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