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    <deviceName>Mycobacterium tuberculosis DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <reference>S3354E-48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:17:07.084Z</lastUpdated>
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    <tradeName>06955792743557</tradeName>
    <deviceName>Monkeypox virus Nucleic Acid Diagnostic Kit (LAMP)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>OSEN GmbH</authorisedRepresentativeName>
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    <deviceName>Monkeypox virus Nucleic Acid Diagnostic Kit (LAMP)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
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    <deviceName>15 High-risk Human Papillomavirus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>OSEN GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:16:58.635Z</lastUpdated>
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    <udiDi>06955792743526</udiDi>
    <basicUdiDi>B-06955792743526</basicUdiDi>
    <tradeName>06955792743526</tradeName>
    <deviceName>15 High-risk Human Papillomavirus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>OSEN GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>SCREENING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3359E-48</reference>
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    <lastUpdated>2026-06-28T18:16:57.444Z</lastUpdated>
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    <basicUdiDi>B-06955792743519</basicUdiDi>
    <tradeName>06955792743519</tradeName>
    <deviceName>Monkeypox Virus (MPV) Rapid Antibody Test Kit (Immunochromatography Assay)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>OSEN GmbH</authorisedRepresentativeName>
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    <emdnDescription>INFECTIOUS IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3358E-50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:16:56.250Z</lastUpdated>
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    <basicUdiDi>B-06955792743502</basicUdiDi>
    <tradeName>06955792743502</tradeName>
    <deviceName>Monkeypox Virus (MPV) Rapid Antibody Test Kit (Immunochromatography Assay)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>OSEN GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>INFECTIOUS IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:16:50.248Z</lastUpdated>
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    <basicUdiDi>B-06955792743496</basicUdiDi>
    <tradeName>06955792743496</tradeName>
    <deviceName>Monkeypox Virus (MPV) Rapid Antibody Test Kit (Immunochromatography Assay)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>OSEN GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000023626</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900299</emdnCode>
    <emdnDescription>INFECTIOUS IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:16:49.031Z</lastUpdated>
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    <udiDi>06955792743489</udiDi>
    <basicUdiDi>B-06955792743489</basicUdiDi>
    <tradeName>06955792743489</tradeName>
    <deviceName>Monkeypox Virus (MPV) Rapid Antibody Test Kit (Immunochromatography Assay)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>OSEN GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000023626</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900299</emdnCode>
    <emdnDescription>INFECTIOUS IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3358E-1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:16:47.829Z</lastUpdated>
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    <udiDi>06955792743472</udiDi>
    <basicUdiDi>B-06955792743472</basicUdiDi>
    <tradeName>06955792743472</tradeName>
    <deviceName>Monkeypox Virus (MPV) Rapid Antigen Test Kit (Immunochromatography Assay)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>OSEN GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000023626</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0105900299</emdnCode>
    <emdnDescription>INFECTIOUS IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3356E-50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:16:46.628Z</lastUpdated>
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    <udiDi>06955792743458</udiDi>
    <basicUdiDi>B-06955792743458</basicUdiDi>
    <tradeName>Monkeypox Virus (MPV) Rapid Antigen Test Kit (Immunochromatography Assay)</tradeName>
    <deviceName>Monkeypox Virus (MPV) Rapid Antigen Test Kit (Immunochromatography Assay)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>OSEN GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000023626</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900299</emdnCode>
    <emdnDescription>INFECTIOUS IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3356E-5</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:16:41.314Z</lastUpdated>
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    <udiDi>06955792743441</udiDi>
    <basicUdiDi>B-06955792743441</basicUdiDi>
    <tradeName>06955792743441</tradeName>
    <deviceName>Monkeypox Virus (MPV) Rapid Antigen Test Kit (Immunochromatography Assay)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>OSEN GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000023626</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900299</emdnCode>
    <emdnDescription>INFECTIOUS IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3356E-1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:16:39.686Z</lastUpdated>
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    <udiDi>06955792743434</udiDi>
    <basicUdiDi>B-06955792743434</basicUdiDi>
    <tradeName>06955792743434</tradeName>
    <deviceName>Human ALDH2 Genetic Polymorphism Detection Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3351E-24-P</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:16:38.289Z</lastUpdated>
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    <udiDi>06955792743427</udiDi>
    <basicUdiDi>B-06955792743427</basicUdiDi>
    <tradeName>06955792743427</tradeName>
    <deviceName>Respiratory Syncytial Virus Rapid Antigen Test (Colloidal Gold Method)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <emdnDescription>RESPIRATORY SYNCYTIAL VIRUS (RSV)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3347E-50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:16:37.604Z</lastUpdated>
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    <udiDi>06955792743410</udiDi>
    <basicUdiDi>B-06955792743410</basicUdiDi>
    <tradeName>06955792743410</tradeName>
    <deviceName>Respiratory Syncytial Virus Rapid Antigen Test (Colloidal Gold Method)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:16:31.054Z</lastUpdated>
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    <tradeName>06955792743403</tradeName>
    <deviceName>Respiratory Syncytial Virus Rapid Antigen Test (Colloidal Gold Method)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:16:29.825Z</lastUpdated>
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    <deviceName>SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (Isothermal Amplification)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3344E-15</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:16:28.618Z</lastUpdated>
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    <tradeName>06955792743380</tradeName>
    <deviceName>SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (Isothermal Amplification)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3344E-1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:16:27.418Z</lastUpdated>
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    <tradeName>06955792743373</tradeName>
    <deviceName>SARS-CoV-2 Multiplex Nucleic Acid Diagnostic Kit (Isothermal Amplification)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3343E-15</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
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    <tradeName>06955792743366</tradeName>
    <deviceName>SARS-CoV-2 Multiplex Nucleic Acid Diagnostic Kit (Isothermal Amplification)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3343E-1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:16:20.211Z</lastUpdated>
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