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    <tradeName>iFlash-IgG4</tradeName>
    <deviceName>iFlash-IgG4</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86089G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:36:15.354Z</lastUpdated>
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    <udiDi>06925912720379</udiDi>
    <basicUdiDi>692591270262HH</basicUdiDi>
    <tradeName>iFlash-IgG3</tradeName>
    <deviceName>iFlash-IgG3</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86088G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:36:11.968Z</lastUpdated>
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    <udiDi>06925912720362</udiDi>
    <basicUdiDi>692591270261HF</basicUdiDi>
    <tradeName>iFlash-IgG2</tradeName>
    <deviceName>iFlash-IgG2</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86087G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:36:11.165Z</lastUpdated>
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    <udiDi>06925912720355</udiDi>
    <basicUdiDi>692591270260HD</basicUdiDi>
    <tradeName>iFlash-IgG1</tradeName>
    <deviceName>iFlash-IgG1</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86086G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:36:07.162Z</lastUpdated>
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    <udiDi>05051700017183</udiDi>
    <basicUdiDi>5051700LK009.OPT55</basicUdiDi>
    <tradeName>Optilite® IgG4 Kit</tradeName>
    <deviceName>Optilite® IgG4 Kit</deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LK009.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:04:52.832Z</lastUpdated>
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    <udiDi>05051700017060</udiDi>
    <basicUdiDi>5051700NK006.OPT5J</basicUdiDi>
    <tradeName>Optilite® IgG1 Kit</tradeName>
    <deviceName>Optilite® IgG1 Kit</deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NK006.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:04:46.323Z</lastUpdated>
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    <udiDi>05051700017039</udiDi>
    <basicUdiDi>5051700LK008.OPT4S</basicUdiDi>
    <tradeName>Optilite® IgG3 Kit</tradeName>
    <deviceName>Optilite® IgG3 Kit</deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LK008.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:04:39.156Z</lastUpdated>
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    <udiDi>05051700017022</udiDi>
    <basicUdiDi>5051700NK007.OPT5V</basicUdiDi>
    <tradeName>Optilite® IgG2 Kit</tradeName>
    <deviceName>Optilite® IgG2 Kit</deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NK007.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:04:37.558Z</lastUpdated>
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  <row>
    <udiDi>06950334824374</udiDi>
    <basicUdiDi>B-06950334824374</basicUdiDi>
    <tradeName>Immunoglobulin G3 (IgG3) Detection Kit</tradeName>
    <deviceName>Immunoglobulin G3 (IgG3) Detection Kit</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32027228</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:36:43.508Z</lastUpdated>
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    <udiDi>06950334824367</udiDi>
    <basicUdiDi>B-06950334824367</basicUdiDi>
    <tradeName>Immunoglobulin G2 (IgG2) Detection Kit</tradeName>
    <deviceName>Immunoglobulin G2 (IgG2) Detection Kit</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32027226</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:36:39.509Z</lastUpdated>
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    <udiDi>06950334824350</udiDi>
    <basicUdiDi>B-06950334824350</basicUdiDi>
    <tradeName>Immunoglobulin G1 (IgG1) Detection Kit</tradeName>
    <deviceName>Immunoglobulin G1 (IgG1) Detection Kit</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32027224</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:36:38.816Z</lastUpdated>
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    <udiDi>05051700007733</udiDi>
    <basicUdiDi>B-05051700007733</basicUdiDi>
    <tradeName>Human IgG2 Subclass Kit (for Siemens BN™II)</tradeName>
    <deviceName>Human IgG2 Subclass Kit (for Siemens BN™II)</deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NK007.TB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:38:52.796Z</lastUpdated>
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    <udiDi>05051700011952</udiDi>
    <basicUdiDi>B-05051700011952</basicUdiDi>
    <tradeName>Human IgG2 Subclass Kit - (for use on the Siemens BN ProSpec®)</tradeName>
    <deviceName>Human IgG2 Subclass Kit - (for use on the Siemens BN ProSpec®)</deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NK007.P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:38:51.193Z</lastUpdated>
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    <udiDi>05051700007641</udiDi>
    <basicUdiDi>B-05051700007641</basicUdiDi>
    <tradeName>Human IgG2 Subclass Bulk Kit (for Siemens BN™II)</tradeName>
    <deviceName>Human IgG2 Subclass Bulk Kit (for Siemens BN™II)</deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NK007.2TB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:38:48.794Z</lastUpdated>
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    <udiDi>05051700007634</udiDi>
    <basicUdiDi>B-05051700007634</basicUdiDi>
    <tradeName>Human IgG1 Subclass Kit (for Siemens BN™II)</tradeName>
    <deviceName>Human IgG1 Subclass Kit (for Siemens BN™II)</deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NK006.TB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:38:34.295Z</lastUpdated>
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    <udiDi>00842768008467</udiDi>
    <basicUdiDi>0405686900985WJ</basicUdiDi>
    <tradeName>N AS IgG2</tradeName>
    <deviceName>IVDR_27_MAR EB_B_REAG_N_AS_IGG2</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446169</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:19:54.348Z</lastUpdated>
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    <udiDi>00842768008450</udiDi>
    <basicUdiDi>0405686900984WG</basicUdiDi>
    <tradeName>N AS IgG1</tradeName>
    <deviceName>IVDR_27_MAR EB_B_REAG_N_AS_IGG1</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
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    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446168</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:19:53.552Z</lastUpdated>
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    <udiDi>00842768006708</udiDi>
    <basicUdiDi>0405686900883W9</basicUdiDi>
    <tradeName>N Latex IgG3</tradeName>
    <deviceName>IVDR_27_MAR EB_B_REAG_N_La_IGG3</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445972</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:19:07.807Z</lastUpdated>
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    <udiDi>00842768006692</udiDi>
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    <tradeName>N Latex IgG4</tradeName>
    <deviceName>IVDR_27_MAR EB_B_REAG_N_La_IGG4</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445971</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:19:07.010Z</lastUpdated>
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    <udiDi>06925912721222</udiDi>
    <basicUdiDi>692591270260HD</basicUdiDi>
    <tradeName>iFlash-IgG1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86086G-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:48:11.077Z</lastUpdated>
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