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    <deviceName>HER-2 DNA Probe Kit (fluorescence in situ hybridization )</deviceName>
    <manufacturerName>Wuhan YZY Medical Science and Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036323</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <lastUpdated>2026-07-06T17:01:30.744Z</lastUpdated>
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    <deviceName>Diagnostic Kit for Novel-Coronavirus (2019-nCoV) RNA (Isothermal Amplification-Real Time Fluorescence Assay)</deviceName>
    <manufacturerName>Ustar Biotechnologies (Hangzhou) Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014615</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <tradeName>Monkeypox Virus Real Time PCR Kit</tradeName>
    <deviceName>Monkeypox Virus Real Time PCR Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <udiDi>06973342003449</udiDi>
    <basicUdiDi>B-06973342003449</basicUdiDi>
    <tradeName>Monkeypox Virus Real Time PCR Kit</tradeName>
    <deviceName>Monkeypox Virus Real Time PCR Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>YJC70115NW-25T</reference>
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    <lastUpdated>2026-07-06T14:08:03.865Z</lastUpdated>
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    <udiDi>06973181850525</udiDi>
    <basicUdiDi>B-06973181850525</basicUdiDi>
    <tradeName>Strongstep® Nucleic acid extraction kit(magnetic beads method)</tradeName>
    <deviceName>Nucleic acid extraction kit(magnetic beads method)</deviceName>
    <manufacturerName>Nanjing Liming Bio-products Co. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041298</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900101</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>504005</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:52:56.685Z</lastUpdated>
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    <basicUdiDi>B-06971760720054</basicUdiDi>
    <tradeName>06971760720054</tradeName>
    <deviceName>Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>QINGDAO HUAREN MEDICAL PRODUCT CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028417</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:46:39.140Z</lastUpdated>
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    <basicUdiDi>B-06971760720047</basicUdiDi>
    <tradeName>06971760720047</tradeName>
    <deviceName>Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>QINGDAO HUAREN MEDICAL PRODUCT CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028417</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests/kit</reference>
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    <basicUdiDi>B-06971760720030</basicUdiDi>
    <tradeName>06971760720030</tradeName>
    <deviceName>Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>QINGDAO HUAREN MEDICAL PRODUCT CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028417</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:46:35.254Z</lastUpdated>
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    <udiDi>06971760720023</udiDi>
    <basicUdiDi>B-06971760720023</basicUdiDi>
    <tradeName>06971760720023</tradeName>
    <deviceName>Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>QINGDAO HUAREN MEDICAL PRODUCT CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028417</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10 tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:46:34.523Z</lastUpdated>
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    <basicUdiDi>B-06971760720016</basicUdiDi>
    <tradeName>06971760720016</tradeName>
    <deviceName>Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>QINGDAO HUAREN MEDICAL PRODUCT CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028417</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5 tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:46:32.530Z</lastUpdated>
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    <udiDi>D-00105900102032ZV</udiDi>
    <basicUdiDi>B-00105900102032ZV</basicUdiDi>
    <tradeName>D-00105900102032ZV</tradeName>
    <deviceName>20 Tests/Kit</deviceName>
    <manufacturerName>Beijing Healthgene Laboratory Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000032465</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 Tests/Kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:10:45.039Z</lastUpdated>
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    <udiDi>09351179000003</udiDi>
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    <tradeName>EasyScreen™ Sample Processing Kit</tradeName>
    <deviceName>EasyScreen™ Sample Processing Kit</deviceName>
    <manufacturerName>Genetic Signatures Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000030901</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900103</emdnCode>
    <emdnDescription>SUPPLEMENTAL NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP012</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:07:04.756Z</lastUpdated>
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    <tradeName>MT-Prep Viral/Pathogen Nucleic Acids Extraction kit B (48 samples)</tradeName>
    <deviceName>Nucleic acid Extraction/isolation Kit IVD</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
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    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>93010</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:05:22.999Z</lastUpdated>
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    <tradeName>Demi DNA Reagent Cassette</tradeName>
    <deviceName>Nucleic acid amplification mastermix reagent IVD</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
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    <tradeName>Extraction Control</tradeName>
    <deviceName>Supplemental NA Reagents</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
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    <emdnDescription>SUPPLEMENTAL NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91401</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
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    <basicUdiDi>924000EX00038G3</basicUdiDi>
    <tradeName>STARprep™ EZ Buffer</tradeName>
    <deviceName>STARprep™ EZ Buffer</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EX00038B</reference>
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    <tradeName>STARMag™ S96H N Kit</tradeName>
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    <manufacturerName>Seegene, Inc.</manufacturerName>
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    <tradeName>STARMag™ S96H Kit</tradeName>
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    <manufacturerName>Seegene, Inc.</manufacturerName>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
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    <tradeName>STARMag™ N/S Kit</tradeName>
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    <manufacturerName>Seegene, Inc.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>STARMag™ M96 Kit</tradeName>
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    <manufacturerName>Seegene, Inc.</manufacturerName>
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