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<eudamedExport entity="devices">
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    <udiDi>06971225930431</udiDi>
    <basicUdiDi>B-06971225930431</basicUdiDi>
    <tradeName>GPP-100 KAP Kit</tradeName>
    <deviceName>GPP-100 KAP 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>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GP44020</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:21:27.472Z</lastUpdated>
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    <udiDi>05204309174515</udiDi>
    <basicUdiDi>5204309000057P7</basicUdiDi>
    <tradeName>LAMBDA FREE LIGHT CHAINS</tradeName>
    <deviceName>LAMBDA FREE LIGHT CHAINS</deviceName>
    <manufacturerName>Medicon Hellas SA</manufacturerName>
    <manufacturerSrn>GR-MF-000013625</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1418-0665</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:54:02.062Z</lastUpdated>
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  <row>
    <udiDi>05204309174508</udiDi>
    <basicUdiDi>5204309000056P5</basicUdiDi>
    <tradeName>KAPPA FREE LIGHT CHAINS</tradeName>
    <deviceName>KAPPA FREE LIGHT CHAINS</deviceName>
    <manufacturerName>Medicon Hellas SA</manufacturerName>
    <manufacturerSrn>GR-MF-000013625</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1418-0655</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:54:01.291Z</lastUpdated>
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    <udiDi>05051700017206</udiDi>
    <basicUdiDi>5051700LK018.OPT57</basicUdiDi>
    <tradeName>Optilite® Freelite® Lambda Free Kit</tradeName>
    <deviceName>Optilite® Freelite® Lambda Free 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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LK018.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:35:58.626Z</lastUpdated>
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  <row>
    <udiDi>06950334822141</udiDi>
    <basicUdiDi>B-06950334822141</basicUdiDi>
    <tradeName>Free Lambda Light Chains (Free LAM) Detection Kit</tradeName>
    <deviceName>Free Lambda Light Chains (Free LAM) 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>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32027221</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:45:00.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950334822134</udiDi>
    <basicUdiDi>B-06950334822134</basicUdiDi>
    <tradeName>Free Kappa Light Chains (Free KAP) Detection Kit</tradeName>
    <deviceName>Free Kappa Light Chains (Free KAP) 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>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32027220</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:44:54.837Z</lastUpdated>
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  <row>
    <udiDi>06950334819752</udiDi>
    <basicUdiDi>B-06950334819752</basicUdiDi>
    <tradeName>Lambda Light Chains (LAM) Detection Kit (Nephelometry)</tradeName>
    <deviceName>Lambda Light Chains (LAM) Detection Kit (Nephelometry)</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>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32027207</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:42:59.311Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950334819745</udiDi>
    <basicUdiDi>B-06950334819745</basicUdiDi>
    <tradeName>Kappa Light Chains (KAP) Detection Kit (Nephelometry)</tradeName>
    <deviceName>Kappa Light Chains (KAP) Detection Kit (Nephelometry)</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>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32027206</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:42:58.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414312453</udiDi>
    <basicUdiDi>0405686902230V4</basicUdiDi>
    <tradeName>N Latex FLC kappa</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873770</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:55:56.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202200182</udiDi>
    <basicUdiDi>B-06942202200182</basicUdiDi>
    <tradeName>Lambda Light Chain Reagent Kit（Immunoturbidimetric Assay）</tradeName>
    <deviceName>Lambda Light Chain Reagent Kit（Immunoturbidimetric Assay）</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3015825</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:49:35.469Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202200175</udiDi>
    <basicUdiDi>B-06942202200175</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Lambda Light Chain Reagent Kit（Immunoturbidimetric Assay）</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3015896</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:49:34.278Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202200168</udiDi>
    <basicUdiDi>B-06942202200168</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Lambda Light Chain Reagent Kit（Immunoturbidimetric Assay）</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3015861</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:49:33.076Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202200151</udiDi>
    <basicUdiDi>B-06942202200151</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Lambda Light Chain Reagent Kit（Immunoturbidimetric Assay）</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3016072</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:49:27.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202200144</udiDi>
    <basicUdiDi>B-06942202200144</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Kappa Light Chain Reagent Kit (Immunoturbidimetric Assay)</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3015970</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:49:25.866Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202200137</udiDi>
    <basicUdiDi>B-06942202200137</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Kappa Light Chain Reagent Kit (Immunoturbidimetric Assay)</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3015856</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:49:24.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202200120</udiDi>
    <basicUdiDi>B-06942202200120</basicUdiDi>
    <tradeName>Kappa Light Chain Reagent Kit (Immunoturbidimetric Assay)</tradeName>
    <deviceName>Kappa Light Chain Reagent Kit (Immunoturbidimetric Assay)</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3015816</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:49:23.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202200113</udiDi>
    <basicUdiDi>B-06942202200113</basicUdiDi>
    <tradeName>Kappa Light Chain Reagent Kit (Immunoturbidimetric Assay)</tradeName>
    <deviceName>Kappa Light Chain Reagent Kit (Immunoturbidimetric Assay)</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3015855</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:49:17.461Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202200106</udiDi>
    <basicUdiDi>B-06942202200106</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>ppa Light Chain Reagent Kit (Immunoturbidimetric Assay)</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3016044</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:49:16.256Z</lastUpdated>
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    <udiDi>06942202200090</udiDi>
    <basicUdiDi>B-06942202200090</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Kappa Light Chain Reagent Kit (Immunoturbidimetric Assay)</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3015815</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:49:15.056Z</lastUpdated>
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  <row>
    <udiDi>06937287300537</udiDi>
    <basicUdiDi>B-06937287300537</basicUdiDi>
    <tradeName>06937287300537</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen AmTech Bioengineering Ltd., Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000043067</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102010109</emdnCode>
    <emdnDescription>KAPPA AND LAMBDA CHAIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1: 2×40 mL, R2: 1×20 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:52:25.227Z</lastUpdated>
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