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<eudamedExport entity="devices">
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    <basicUdiDi>69449040004MCysC*******Q4</basicUdiDi>
    <tradeName>Cystatin C Kit (Latex Immunoturbidimetric Method)</tradeName>
    <deviceName>Cystatin C Kit (Latex Immunoturbidimetric Method) 、Cystatin C Calibrator、Cystatin C Control</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>IVDR 2017/746</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004638-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:54:13.477Z</lastUpdated>
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    <udiDi>04050598156005</udiDi>
    <basicUdiDi>B-04050598156005</basicUdiDi>
    <tradeName>IDK® Zonulin ELISA</tradeName>
    <deviceName>IDK® Zonulin ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 5600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:37.512Z</lastUpdated>
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    <udiDi>04050598162105</udiDi>
    <basicUdiDi>B-04050598162105</basicUdiDi>
    <tradeName>β2-Mikroglobulin ELISA</tradeName>
    <deviceName>β2-Mikroglobulin ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 6210</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:37.464Z</lastUpdated>
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    <udiDi>04050598165007</udiDi>
    <basicUdiDi>B-04050598165007</basicUdiDi>
    <tradeName>β-Defensin 2 ELISA</tradeName>
    <deviceName>β-Defensin 2 ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 6500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:37.347Z</lastUpdated>
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    <udiDi>04050598166004</udiDi>
    <basicUdiDi>B-04050598166004</basicUdiDi>
    <tradeName>L-Citrullin</tradeName>
    <deviceName>L-Citrullin</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 6600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:37.266Z</lastUpdated>
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  <row>
    <udiDi>04050598166103</udiDi>
    <basicUdiDi>B-04050598166103</basicUdiDi>
    <tradeName>α2-Makroglobulin ELISA</tradeName>
    <deviceName>α2-Makroglobulin ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019003</emdnCode>
    <emdnDescription>A2-MACROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 6610</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:37.232Z</lastUpdated>
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    <udiDi>04050598167100</udiDi>
    <basicUdiDi>B-04050598167100</basicUdiDi>
    <tradeName>α1-Mikroglobulin ELISA</tradeName>
    <deviceName>α1-Mikroglobulin ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019004</emdnCode>
    <emdnDescription>A1-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 6710</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:37.185Z</lastUpdated>
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  <row>
    <udiDi>04050598167506</udiDi>
    <basicUdiDi>B-04050598167506</basicUdiDi>
    <tradeName>IDK® α1-Antitrypsin ELISA</tradeName>
    <deviceName>IDK® α1-Antitrypsin ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019002</emdnCode>
    <emdnDescription>A1-ANTITRYPSIN (PROTEASE INHIBITOR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 6750</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:37.162Z</lastUpdated>
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    <udiDi>04050598167520</udiDi>
    <basicUdiDi>B-04050598167520</basicUdiDi>
    <tradeName>IDK® α1-Antitrypsin Clearance ELISA</tradeName>
    <deviceName>IDK® α1-Antitrypsin Clearance ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019002</emdnCode>
    <emdnDescription>A1-ANTITRYPSIN (PROTEASE INHIBITOR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 6752</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:37.131Z</lastUpdated>
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  <row>
    <udiDi>04050598168114</udiDi>
    <basicUdiDi>B-04050598168114</basicUdiDi>
    <tradeName>IDK® EDN ELISA</tradeName>
    <deviceName>IDK® EDN ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 6811</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:37.107Z</lastUpdated>
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  <row>
    <udiDi>04050598169272</udiDi>
    <basicUdiDi>B-04050598169272</basicUdiDi>
    <tradeName>IDK® Calprotectin ELISA</tradeName>
    <deviceName>IDK® Calprotectin ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 6927</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:36.973Z</lastUpdated>
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  <row>
    <udiDi>04050598169357</udiDi>
    <basicUdiDi>B-04050598169357</basicUdiDi>
    <tradeName>IDK® Calprotectin ELISA</tradeName>
    <deviceName>IDK® Calprotectin ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 6935</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:36.931Z</lastUpdated>
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  <row>
    <udiDi>04050598169388</udiDi>
    <basicUdiDi>B-04050598169388</basicUdiDi>
    <tradeName>IDK® S100A12 ELISA</tradeName>
    <deviceName>IDK® S100A12 ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 6938</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:36.896Z</lastUpdated>
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    <udiDi>05060169696822</udiDi>
    <basicUdiDi>5060169696822YP</basicUdiDi>
    <tradeName>IDS Fluid Calprotectin</tradeName>
    <deviceName>IDS Fluid Calprotectin</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-AI26100</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:33:13.896Z</lastUpdated>
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    <udiDi>05060169696280</udiDi>
    <basicUdiDi>5060169696280Y7</basicUdiDi>
    <tradeName>05060169696280</tradeName>
    <deviceName>IDS Calprotectin</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-AI26000</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:33:03.493Z</lastUpdated>
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    <udiDi>05056013025689</udiDi>
    <basicUdiDi>505601300ULTCESPE6</basicUdiDi>
    <tradeName>UltraCE Serum Protein</tradeName>
    <deviceName>UltraCE Serum Protein</deviceName>
    <manufacturerName>Helena Biosciences Europe</manufacturerName>
    <manufacturerSrn>GB-MF-000028365</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V8100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:22:07.666Z</lastUpdated>
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    <udiDi>05056013007944</udiDi>
    <basicUdiDi>5056013005BANDM8</basicUdiDi>
    <tradeName>SAS-MX SP-10 Kit</tradeName>
    <deviceName>Serum Protein Kits</deviceName>
    <manufacturerName>Helena Biosciences Europe</manufacturerName>
    <manufacturerSrn>GB-MF-000028365</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100100</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:22:02.856Z</lastUpdated>
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    <udiDi>05051700019361</udiDi>
    <basicUdiDi>5051700NK036.U.OPTQM</basicUdiDi>
    <tradeName>Optilite® Alpha-1-Microglobulin Urine Control Pack</tradeName>
    <deviceName>Optilite® Alpha-1-microglobulin Urine 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>W0102019004</emdnCode>
    <emdnDescription>A1-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NQ036.U.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:05:49.084Z</lastUpdated>
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    <udiDi>05051700019354</udiDi>
    <basicUdiDi>5051700NK039.U.OPTS8</basicUdiDi>
    <tradeName>Optilite® Alpha-2-Macroglobulin Urine Control Pack</tradeName>
    <deviceName>Optilite® Alpha-2-Macroglobulin Urine 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>W0102019003</emdnCode>
    <emdnDescription>A2-MACROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NQ039.U.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:05:48.339Z</lastUpdated>
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    <udiDi>05051700017442</udiDi>
    <basicUdiDi>5051700NK039.OPT7S</basicUdiDi>
    <tradeName>Optilite® Alpha-2-Macroglobulin Kit</tradeName>
    <deviceName>Optilite® Alpha-2-Macroglobulin 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>W0102019003</emdnCode>
    <emdnDescription>A2-MACROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NK039.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:05:09.646Z</lastUpdated>
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