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    <tradeName>Direct NEXUS Nasal Aspirator</tradeName>
    <deviceName>Nasal Aspirator</deviceName>
    <manufacturerName>Dongguan Rongfeng Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000053840</manufacturerSrn>
    <authorisedRepresentativeName>OSEN GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000023626</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>MUCOSITY ASPIRATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DN001</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
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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>
    <authorisedRepresentativeSrn>DE-AR-000023626</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3361E-48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:17:05.857Z</lastUpdated>
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    <basicUdiDi>B-06955792743540</basicUdiDi>
    <tradeName>06955792743540</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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    <legislation>IVDD</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3361E-24</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:16:59.839Z</lastUpdated>
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    <basicUdiDi>B-06955792743533</basicUdiDi>
    <tradeName>06955792743533</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>
    <authorisedRepresentativeSrn>DE-AR-000023626</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041002</emdnCode>
    <emdnDescription>SCREENING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3359E-12</reference>
    <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>
    <authorisedRepresentativeSrn>DE-AR-000023626</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041002</emdnCode>
    <emdnDescription>SCREENING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3359E-48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:16:57.444Z</lastUpdated>
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    <udiDi>06955792743519</udiDi>
    <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>
    <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-50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:16:56.250Z</lastUpdated>
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    <udiDi>06955792743502</udiDi>
    <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>
    <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-25</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:16:50.248Z</lastUpdated>
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    <udiDi>06955792743496</udiDi>
    <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>
    <reference>S3358E-5</reference>
    <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>
    <legislation>IVDD</legislation>
    <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>06972524540383</udiDi>
    <basicUdiDi>697252454DQZR</basicUdiDi>
    <tradeName>Romo Health Nasal Aspirator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dongguan Rongfeng Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000053840</manufacturerSrn>
    <authorisedRepresentativeName>OSEN GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000023626</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R05010399</emdnCode>
    <emdnDescription>MUCOSITY ASPIRATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DQ22</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:34:37.876Z</lastUpdated>
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    <basicUdiDi>697252454DQZR</basicUdiDi>
    <tradeName>Romo Health Nasal Aspirator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dongguan Rongfeng Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000053840</manufacturerSrn>
    <authorisedRepresentativeName>OSEN GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000023626</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R05010399</emdnCode>
    <emdnDescription>MUCOSITY ASPIRATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DQ25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:34:37.857Z</lastUpdated>
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    <udiDi>D-WI-GON-C71-25FZ</udiDi>
    <basicUdiDi>B-WI-GON-C71-25FZ</basicUdiDi>
    <tradeName>Bio·Firm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Wantaifu Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000037582</manufacturerSrn>
    <authorisedRepresentativeName>OSEN GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000023626</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WI-GON-C71-25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:52:15.786Z</lastUpdated>
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