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    <manufacturerName>Ningbo HEALTH Gene Technologies Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002278</manufacturerSrn>
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    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XC15033</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:51:21.118Z</lastUpdated>
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    <udiDi>06937044500781</udiDi>
    <basicUdiDi>B-06937044500781</basicUdiDi>
    <tradeName>06937044500781</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo HEALTH Gene Technologies Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002278</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XC25079</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:51:19.927Z</lastUpdated>
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    <udiDi>06937044500774</udiDi>
    <basicUdiDi>B-06937044500774</basicUdiDi>
    <tradeName>06937044500774</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo HEALTH Gene Technologies Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002278</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XC25103</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:51:18.724Z</lastUpdated>
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    <udiDi>06937044500392</udiDi>
    <basicUdiDi>B-06937044500392</basicUdiDi>
    <tradeName>06937044500392</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo HEALTH Gene Technologies Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002278</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XC123</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:51:00.708Z</lastUpdated>
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    <udiDi>06937044500378</udiDi>
    <basicUdiDi>B-06937044500378</basicUdiDi>
    <tradeName>06937044500378</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo HEALTH Gene Technologies Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002278</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XC111</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:50:58.308Z</lastUpdated>
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    <udiDi>06937044500361</udiDi>
    <basicUdiDi>B-06937044500361</basicUdiDi>
    <tradeName>06937044500361</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo HEALTH Gene Technologies Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002278</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XC101</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:50:55.917Z</lastUpdated>
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    <udiDi>06937044500354</udiDi>
    <basicUdiDi>B-06937044500354</basicUdiDi>
    <tradeName>06937044500354</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo HEALTH Gene Technologies Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002278</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XC98</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:50:54.712Z</lastUpdated>
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    <udiDi>06937044500330</udiDi>
    <basicUdiDi>B-06937044500330</basicUdiDi>
    <tradeName>06937044500330</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo HEALTH Gene Technologies Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002278</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XC99</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:50:52.341Z</lastUpdated>
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    <udiDi>06937044500323</udiDi>
    <basicUdiDi>B-06937044500323</basicUdiDi>
    <tradeName>06937044500323</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo HEALTH Gene Technologies Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002278</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XC25187</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:50:49.914Z</lastUpdated>
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    <udiDi>06937044500057</udiDi>
    <basicUdiDi>B-06937044500057</basicUdiDi>
    <tradeName>06937044500057</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo HEALTH Gene Technologies Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002278</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1060091</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T18:50:35.504Z</lastUpdated>
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    <udiDi>06936595752434</udiDi>
    <basicUdiDi>B-06936595752434</basicUdiDi>
    <tradeName>SARS-CoV-2 Neutralizing Antibody Test Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG1999Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:59:02.004Z</lastUpdated>
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    <udiDi>06936595752304</udiDi>
    <basicUdiDi>B-06936595752304</basicUdiDi>
    <tradeName>Monkeypox Virus Real Time PCR Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YG2014Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:58:42.789Z</lastUpdated>
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    <udiDi>06936595752267</udiDi>
    <basicUdiDi>B-06936595752267</basicUdiDi>
    <tradeName>COVID-19 &amp; Influenza Antigen Rapid Test Cassette</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CG2304TY</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:58:37.984Z</lastUpdated>
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    <udiDi>06936595752250</udiDi>
    <basicUdiDi>B-06936595752250</basicUdiDi>
    <tradeName>Influenza A+B Rapid Test Cassette</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CG2303TY</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:58:35.570Z</lastUpdated>
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    <udiDi>06936595752243</udiDi>
    <basicUdiDi>B-06936595752243</basicUdiDi>
    <tradeName>Coronavirus Disease 2019 Antibody  (IgM/IgG) Combined Test Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CG2301Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:58:34.400Z</lastUpdated>
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    <udiDi>06936595751932</udiDi>
    <basicUdiDi>B-06936595751932</basicUdiDi>
    <tradeName>SARS-CoV-2 RT-PCR Test Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCR5101Y1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:58:05.581Z</lastUpdated>
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    <udiDi>06936595751765</udiDi>
    <basicUdiDi>B-06936595751765</basicUdiDi>
    <tradeName>Coronavirus Disease 2019 Real Time PCR Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCR5101Y1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:40.336Z</lastUpdated>
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    <udiDi>06936595751758</udiDi>
    <basicUdiDi>B-06936595751758</basicUdiDi>
    <tradeName>COVID-19 Ag Rapid Test Cassette</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CG2302TY1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:39.128Z</lastUpdated>
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    <udiDi>06936020115414</udiDi>
    <basicUdiDi>B-06936020115414</basicUdiDi>
    <tradeName>Singclean®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040532</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX - NA REAGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVD76-02-20t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:09:49.726Z</lastUpdated>
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    <udiDi>06936020115407</udiDi>
    <basicUdiDi>B-06936020115407</basicUdiDi>
    <tradeName>Singclean®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040532</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX - NA REAGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVD76-02-5t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:09:48.516Z</lastUpdated>
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