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<eudamedExport entity="devices">
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    <tradeName>06975225462435</tradeName>
    <deviceName>Immunoglobulin M Assay Kit (Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Da Te Bioengineering Technology Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028832</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010107</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN M</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTSH090508</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:16:51.885Z</lastUpdated>
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    <udiDi>06975225462428</udiDi>
    <basicUdiDi>B-06975225462428</basicUdiDi>
    <tradeName>06975225462428</tradeName>
    <deviceName>Immunoglobulin M Assay Kit (Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Da Te Bioengineering Technology Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028832</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010107</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN M</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTSH090507</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:16:47.876Z</lastUpdated>
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    <udiDi>06975225462411</udiDi>
    <basicUdiDi>B-06975225462411</basicUdiDi>
    <tradeName>06975225462411</tradeName>
    <deviceName>Immunoglobulin M Assay Kit (Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Da Te Bioengineering Technology Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028832</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010107</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN M</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTSH090506</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:16:47.077Z</lastUpdated>
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    <udiDi>06975225462404</udiDi>
    <basicUdiDi>B-06975225462404</basicUdiDi>
    <tradeName>06975225462404</tradeName>
    <deviceName>Immunoglobulin M Assay Kit (Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Da Te Bioengineering Technology Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028832</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010107</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN M</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTSH090505</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:16:46.280Z</lastUpdated>
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    <udiDi>06975225462398</udiDi>
    <basicUdiDi>B-06975225462398</basicUdiDi>
    <tradeName>06975225462398</tradeName>
    <deviceName>Immunoglobulin M Assay Kit (Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Da Te Bioengineering Technology Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028832</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010107</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN M</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTSH090504</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:16:45.481Z</lastUpdated>
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  <row>
    <udiDi>06971674867739</udiDi>
    <basicUdiDi>B-06971674867739</basicUdiDi>
    <tradeName>Immune Globulin M (IgM) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Immune Globulin M (IgM) Test Kit (Immunoturbidimetric)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010107</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN M</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:50mL×2  R2:10mL×2(713)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:36:52.673Z</lastUpdated>
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  <row>
    <udiDi>06971674867722</udiDi>
    <basicUdiDi>B-06971674867722</basicUdiDi>
    <tradeName>Immune Globulin M (IgM) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Immune Globulin M (IgM) Test Kit (Immunoturbidimetric)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010107</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN M</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:100mL×1  R2:20mL×1(708)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:36:49.882Z</lastUpdated>
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  <row>
    <udiDi>06971674867715</udiDi>
    <basicUdiDi>B-06971674867715</basicUdiDi>
    <tradeName>Immune Globulin M (IgM) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Immune Globulin M (IgM) Test Kit (Immunoturbidimetric)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010107</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN M</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:50mL×2  R2:10mL×2(705)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:36:46.080Z</lastUpdated>
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    <udiDi>06971674867708</udiDi>
    <basicUdiDi>B-06971674867708</basicUdiDi>
    <tradeName>Immune Globulin M (IgM) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Immune Globulin M (IgM) Test Kit (Immunoturbidimetric)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010107</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN M</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:25mL×1  R2:5mL×1(702)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:36:45.682Z</lastUpdated>
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  <row>
    <udiDi>06971674867692</udiDi>
    <basicUdiDi>B-06971674867692</basicUdiDi>
    <tradeName>Immune Globulin M (IgM) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Immune Globulin M (IgM) Test Kit (Immunoturbidimetric)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010107</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN M</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:25mL×4  R2:5mL×4(709)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:36:44.390Z</lastUpdated>
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  <row>
    <udiDi>06971674867685</udiDi>
    <basicUdiDi>B-06971674867685</basicUdiDi>
    <tradeName>Immune Globulin M (IgM) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Immune Globulin M (IgM) Test Kit (Immunoturbidimetric)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010107</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN M</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:60mL×2  R2:12mL×2(701)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:36:43.030Z</lastUpdated>
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  <row>
    <udiDi>06971674867678</udiDi>
    <basicUdiDi>B-06971674867678</basicUdiDi>
    <tradeName>Immune Globulin M (IgM) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Immune Globulin M (IgM) Test Kit (Immunoturbidimetric)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010107</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN M</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:70mL×2  R2:14mL×2(700)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:36:40.903Z</lastUpdated>
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  <row>
    <udiDi>06971225939618</udiDi>
    <basicUdiDi>B-06971225939618</basicUdiDi>
    <tradeName>Omlipo IgM Kit</tradeName>
    <deviceName>Omlipo IgM Kit</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010107</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN M</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP09100</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:30:30.989Z</lastUpdated>
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  <row>
    <udiDi>06971225933715</udiDi>
    <basicUdiDi>B-06971225933715</basicUdiDi>
    <tradeName>Nephstar IgM Kit</tradeName>
    <deviceName>Nephstar IgM Kit</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010107</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN M</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DK009</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:27:09.011Z</lastUpdated>
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    <udiDi>06971225930585</udiDi>
    <basicUdiDi>B-06971225930585</basicUdiDi>
    <tradeName>Omlipo IgM Kit</tradeName>
    <deviceName>Omlipo IgM Kit</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010107</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN M</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP09050</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:22:01.146Z</lastUpdated>
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    <udiDi>06971225930189</udiDi>
    <basicUdiDi>B-06971225930189</basicUdiDi>
    <tradeName>GPP-100 IgM Kit</tradeName>
    <deviceName>GPP-100 IgM Kit</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010107</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN M</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GP09020</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:20:32.181Z</lastUpdated>
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  <row>
    <udiDi>05415168001793</udiDi>
    <basicUdiDi>B-05415168001793</basicUdiDi>
    <tradeName>Immunoglobulin M</tradeName>
    <deviceName>Immunoglobulin M</deviceName>
    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010107</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN M</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMTUR-H00/ADV</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:32:52.611Z</lastUpdated>
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  <row>
    <udiDi>06944904025384</udiDi>
    <basicUdiDi>694490400044IGM********K5</basicUdiDi>
    <tradeName>Immunoglobulin M Kit (Turbidimetry Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102010107</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN M</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-000882-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:11:01.679Z</lastUpdated>
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    <udiDi>06944904050843</udiDi>
    <basicUdiDi>694490400044IGM********K5</basicUdiDi>
    <tradeName>Immunoglobulin M Kit (Turbidimetry Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102010107</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN M</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004606-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:28.753Z</lastUpdated>
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  <row>
    <udiDi>03610230005675</udiDi>
    <basicUdiDi>B-03610230005675</basicUdiDi>
    <tradeName>ABX Pentra Ig M CP</tradeName>
    <deviceName>ABX Pentra Ig M CP</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010107</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN M</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A11A01925</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T14:00:02.759Z</lastUpdated>
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