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    <manufacturerName>MacroArray Diagnostics</manufacturerName>
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    <tradeName>Biossays Immunoglobulin G (Latex Immunoturbidimetric)</tradeName>
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    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <tradeName>Biossays Immunoglobulin G Calibrators</tradeName>
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    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
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    <tradeName>Biossays Immunoglobulin G Controls</tradeName>
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    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
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    <deviceName>IMMUNOGLOBULIN G (IgG)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
    <emdnCode>W0102010105</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13081</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:48:01.565Z</lastUpdated>
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    <tradeName>08435287110814</tradeName>
    <deviceName>IMMUNOGLOBULIN G (IgG)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceName>IMMUNOGLOBULIN G (IgG)</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
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    <deviceName>IMMUNOGLOBULIN G (IgG)</deviceName>
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    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
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    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:43:25.147Z</lastUpdated>
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    <basicUdiDi>B-06976043630150</basicUdiDi>
    <tradeName>06976043630150</tradeName>
    <deviceName>Immunoglobulin G (IgG) Assay Kit</deviceName>
    <manufacturerName>iCarbonX IntelliCore (Guangdong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045482</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010105</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>015</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:27:10.239Z</lastUpdated>
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    <udiDi>06975225462381</udiDi>
    <basicUdiDi>B-06975225462381</basicUdiDi>
    <tradeName>06975225462381</tradeName>
    <deviceName>Immunoglobulin G 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>W0102010105</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTSH090411</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:16:41.470Z</lastUpdated>
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    <tradeName>06975225462374</tradeName>
    <deviceName>Immunoglobulin G 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>
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    <emdnCode>W0102010105</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTSH090401</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:16:40.777Z</lastUpdated>
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    <tradeName>06975225462367</tradeName>
    <deviceName>Immunoglobulin G 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>W0102010105</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTSH090410</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:16:39.072Z</lastUpdated>
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    <basicUdiDi>B-06975225462350</basicUdiDi>
    <tradeName>06975225462350</tradeName>
    <deviceName>Immunoglobulin G 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>W0102010105</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTSH090409</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:16:38.278Z</lastUpdated>
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    <udiDi>06975225462343</udiDi>
    <basicUdiDi>B-06975225462343</basicUdiDi>
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    <deviceName>Immunoglobulin G Assay Kit (Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Da Te Bioengineering Technology Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028832</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTSH090408</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:16:34.266Z</lastUpdated>
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    <deviceName>Immunoglobulin G Assay Kit (Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Da Te Bioengineering Technology Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028832</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <emdnCode>W0102010105</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTSH090407</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:16:33.460Z</lastUpdated>
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    <deviceName>Immunoglobulin G Assay Kit (Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Da Te Bioengineering Technology Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028832</manufacturerSrn>
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    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTSH090406</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:16:32.662Z</lastUpdated>
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    <tradeName>06975225462312</tradeName>
    <deviceName>Immunoglobulin G Assay Kit (Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Da Te Bioengineering Technology Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000028832</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTSH090405</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:16:31.865Z</lastUpdated>
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    <basicUdiDi>B-06971674867906</basicUdiDi>
    <tradeName>Immune Globulin G (IgG) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Immune Globulin G (IgG) Test Kit (Immunoturbidimetric)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
    <emdnCode>W0102010105</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Calibrator：1mL×1(91020)</reference>
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    <lastUpdated>2026-07-06T10:37:24.668Z</lastUpdated>
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    <tradeName>Immune Globulin G (IgG) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Immune Globulin G (IgG) Test Kit (Immunoturbidimetric)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <lastUpdated>2026-07-06T10:36:39.272Z</lastUpdated>
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    <tradeName>Immune Globulin G (IgG) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Immune Globulin G (IgG) Test Kit (Immunoturbidimetric)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-06T10:36:36.970Z</lastUpdated>
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