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    <basicUdiDi>B-06952804825997</basicUdiDi>
    <tradeName>06952804825997</tradeName>
    <deviceName>Carcinoembryonic Antigen Chemiluminescence Immunoassay Test Kit</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G207A08X</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:32:39.898Z</lastUpdated>
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    <udiDi>06952804825980</udiDi>
    <basicUdiDi>B-06952804825980</basicUdiDi>
    <tradeName>06952804825980</tradeName>
    <deviceName>Alpha Fetoprotein Chemiluminescence Immunoassay Test Kit</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G200A08X</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:32:36.358Z</lastUpdated>
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    <udiDi>00860000930949</udiDi>
    <basicUdiDi>B-00860000930949</basicUdiDi>
    <tradeName>Ora-3D</tradeName>
    <deviceName>Ora-3D</deviceName>
    <manufacturerName>Vigilant Biosciences, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013534</manufacturerSrn>
    <authorisedRepresentativeName>Vigilant Biosciences GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000028648</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9000006</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:44:53.225Z</lastUpdated>
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    <udiDi>06970221769106</udiDi>
    <basicUdiDi>B-06970221769106</basicUdiDi>
    <tradeName>FOB Rapid Test</tradeName>
    <deviceName>FOB Rapid Test</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VTFO-U602</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:36:02.820Z</lastUpdated>
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    <udiDi>06942598212493</udiDi>
    <basicUdiDi>B-06942598212493</basicUdiDi>
    <tradeName>DiaRapid CEA Rapid Test Cassette</tradeName>
    <deviceName>DiaRapid CEA Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCE-402</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-26T22:20:04.264Z</lastUpdated>
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    <udiDi>06942598212486</udiDi>
    <basicUdiDi>B-06942598212486</basicUdiDi>
    <tradeName>DiaRapid AFP Rapid Test Cassette</tradeName>
    <deviceName>DiaRapid AFP Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAF-402</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-26T22:20:00.444Z</lastUpdated>
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    <udiDi>06937339210166</udiDi>
    <basicUdiDi>B-06937339210166</basicUdiDi>
    <tradeName>FOB Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VTFO-U602</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:57:59.027Z</lastUpdated>
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    <udiDi>06937339209559</udiDi>
    <basicUdiDi>B-06937339209559</basicUdiDi>
    <tradeName>AFP Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VTAF-402</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:56:40.976Z</lastUpdated>
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    <udiDi>06937339209528</udiDi>
    <basicUdiDi>B-06937339209528</basicUdiDi>
    <tradeName>CEA Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VTCE-402</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:56:37.369Z</lastUpdated>
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  <row>
    <udiDi>06937339203441</udiDi>
    <basicUdiDi>B-06937339203441</basicUdiDi>
    <tradeName>FOB Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VTFO-U602</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:53:14.451Z</lastUpdated>
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