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    <basicUdiDi>B-0000128071400A3PD</basicUdiDi>
    <tradeName>Human Papillomavirus (28 Types) Genotyping Detection Kit (Fluorescence PCR)</tradeName>
    <deviceName>Human Papillomavirus (28 Types) Genotyping Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041003</emdnCode>
    <emdnDescription>PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-CC007</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:58:13.939Z</lastUpdated>
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    <udiDi>D-0000128071390DAS4</udiDi>
    <basicUdiDi>B-0000128071390DAS4</basicUdiDi>
    <tradeName>Freeze-dried Mycobacterium Tuberculosis Nucleic Acid and Rifampicin, Isoniazid Resistance Detection Kit (Melting Curve)</tradeName>
    <deviceName>Freeze-dried Mycobacterium Tuberculosis Nucleic Acid and Rifampicin, Isoniazid Resistance Detection Kit (Melting Curve)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-RT105</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:58:11.536Z</lastUpdated>
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    <udiDi>D-000012807086165QZ</udiDi>
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    <tradeName>Dengue NS1 Antigen, IgM/IgG Antibody Dual Detection Kit (Immunochromatography)</tradeName>
    <deviceName>Dengue NS1 Antigen, IgM/IgG Antibody Dual Detection Kit (Immunochromatography)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-FE031A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:58:09.931Z</lastUpdated>
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    <udiDi>D-000012807042309NR</udiDi>
    <basicUdiDi>B-000012807042309NR</basicUdiDi>
    <tradeName>Freeze-dried Mycobacterium Tuberculosis DNA Detection Kit (Fluorescence PCR)</tradeName>
    <deviceName>Freeze-dried Mycobacterium Tuberculosis DNA Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010799</emdnCode>
    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-RT105C</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:58:09.128Z</lastUpdated>
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    <udiDi>D-000012807086266R8</udiDi>
    <basicUdiDi>B-000012807086266R8</basicUdiDi>
    <tradeName>Dengue NS1 Antigen, IgM/IgG Antibody Dual Detection Kit (Immunochromatography)</tradeName>
    <deviceName>Dengue NS1 Antigen, IgM/IgG Antibody Dual Detection Kit (Immunochromatography)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-FE031B</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:58:07.625Z</lastUpdated>
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    <udiDi>D-000012807042208NJ</udiDi>
    <basicUdiDi>B-000012807042208NJ</basicUdiDi>
    <tradeName>Freeze-dried Mycobacterium Tuberculosis DNA Detection Kit (Fluorescence PCR)</tradeName>
    <deviceName>Freeze-dried Mycobacterium Tuberculosis DNA Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-RT105A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:57:53.873Z</lastUpdated>
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    <udiDi>D-00001280704210BNX</udiDi>
    <basicUdiDi>B-00001280704210BNX</basicUdiDi>
    <tradeName>Freeze-dried Mycobacterium Tuberculosis DNA Detection Kit (Fluorescence PCR)</tradeName>
    <deviceName>Freeze-dried Mycobacterium Tuberculosis DNA Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-RT105B</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:57:49.871Z</lastUpdated>
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    <udiDi>06974849369649</udiDi>
    <basicUdiDi>697484936HWTS-OT149A5A</basicUdiDi>
    <tradeName>Carbapenem Resistance Gene Detection Kit (Fluorescence PCR)</tradeName>
    <deviceName>Carbapenem Resistance Gene Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080606</emdnCode>
    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-OT149A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:37:01.739Z</lastUpdated>
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    <udiDi>06974849369595</udiDi>
    <basicUdiDi>697484936W01050405V2</basicUdiDi>
    <tradeName>Freeze-dried Influenza A Virus/Influenza B Virus Nucleic Acid Detection Kit  (Fluorescence PCR)</tradeName>
    <deviceName>Freeze-dried Influenza A Virus/Influenza B Virus Nucleic Acid Detection Kit  (Fluorescence PCR)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-RT176A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:36:45.680Z</lastUpdated>
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    <udiDi>06974849368680</udiDi>
    <basicUdiDi>697484936RT177AVK</basicUdiDi>
    <tradeName>Freeze-dried Six Respiratory Pathogens Nucleic Acid Detection Kit  (Fluorescence PCR)</tradeName>
    <deviceName>Freeze-dried Six Respiratory Pathogens Nucleic Acid Detection Kit  (Fluorescence PCR)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-RT177A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:36:43.313Z</lastUpdated>
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    <udiDi>06974849366785</udiDi>
    <basicUdiDi>697484936W0599NY</basicUdiDi>
    <tradeName>Sputasol</tradeName>
    <deviceName>Sputasol</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-3012C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:36:41.682Z</lastUpdated>
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    <udiDi>06974849366716</udiDi>
    <basicUdiDi>697484936W0201020201DG</basicUdiDi>
    <tradeName>Macro &amp; Micro-Test Fluorescence Reader</tradeName>
    <deviceName>Macro &amp; Micro-Test Fluorescence Reader</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-EQ005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:36:40.873Z</lastUpdated>
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    <basicUdiDi>697484936W02069099YC</basicUdiDi>
    <tradeName>Macro &amp; Micro-Test Automatic Nucleic Acid Extractor</tradeName>
    <deviceName>Macro &amp; Micro-Test Automatic Nucleic Acid Extractor</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069099</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-3006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:36:39.279Z</lastUpdated>
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    <basicUdiDi>697484936W0105900101HP</basicUdiDi>
    <tradeName>Macro &amp; Micro-Test Viral DNA/RNA Kit</tradeName>
    <deviceName>Macro &amp; Micro-Test Viral DNA/RNA Kit</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-3017-50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:36:36.879Z</lastUpdated>
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    <udiDi>06974849366389</udiDi>
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    <tradeName>Easy Amp Real-time Fluorescence Isothermal Detection System</tradeName>
    <deviceName>Easy Amp Real-time Fluorescence Isothermal Detection System  (HWTS 1600)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-EQ002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:36:35.308Z</lastUpdated>
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    <basicUdiDi>697484936W05019099Y8</basicUdiDi>
    <tradeName>Macro &amp; Micro-Test Sample Collecting, Mailing &amp; Shipping Kit</tradeName>
    <deviceName>Macro &amp; Micro-Test Sample Collecting, Mailing &amp; Shipping Kit</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-3008-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:36:34.495Z</lastUpdated>
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    <tradeName>Nucleic Acid Detection Kit for Clostridium Difficile toxin A/B gene (Fluorescence PCR)</tradeName>
    <deviceName>Nucleic Acid Detection Kit for Clostridium Difficile toxin A/B gene (Fluorescence PCR)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>C.DIFFICILE TOXIN A/B DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-EV032A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:36:32.875Z</lastUpdated>
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    <tradeName>Freeze-dried Six Respiratory Pathogens Nucleic Acid Detection Kit  (Fluorescence PCR)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-RT177B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-17T03:48:54.006Z</lastUpdated>
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    <tradeName>Freeze-dried Six Respiratory Pathogens Nucleic Acid Detection Kit  (Fluorescence PCR)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-RT177C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-17T03:48:53.912Z</lastUpdated>
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    <tradeName>Freeze-dried Six Respiratory Pathogens Nucleic Acid Detection Kit  (Fluorescence PCR)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-RT177E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-17T03:48:53.608Z</lastUpdated>
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