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<eudamedExport entity="devices">
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    <udiDi>04050598000964</udiDi>
    <basicUdiDi>B-04050598000964</basicUdiDi>
    <tradeName>IDK® Kynurenine ELISA</tradeName>
    <deviceName>IDK® Kynurenine 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 7728</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:40:14.228Z</lastUpdated>
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  <row>
    <udiDi>04050598000728</udiDi>
    <basicUdiDi>B-04050598000728</basicUdiDi>
    <tradeName>Nitrotyrosin (EDTA-Plasma, Serum, Trockenblut) ELISA</tradeName>
    <deviceName>Nitrotyrosin (EDTA-Plasma, Serum, Trockenblut) 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 7829</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:40:05.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000704</udiDi>
    <basicUdiDi>B-04050598000704</basicUdiDi>
    <tradeName>Nitrotyrosin (Stuhl, Plasma, Serum) ELISA</tradeName>
    <deviceName>Nitrotyrosin (Stuhl, Plasma, Serum) 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 7824</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:40:03.820Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000650</udiDi>
    <basicUdiDi>B-04050598000650</basicUdiDi>
    <tradeName>IDK® Tryptophan (EDTA plasma, serum, dried blood) ELISA</tradeName>
    <deviceName>IDK® Tryptophan (EDTA plasma, serum, dried blood) 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 7730M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:39:57.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000513</udiDi>
    <basicUdiDi>B-04050598000513</basicUdiDi>
    <tradeName>IDK® Tryptophan (EDTA plasma, serum, dried blood) ELISA</tradeName>
    <deviceName>IDK® Tryptophan (EDTA plasma, serum, dried blood) 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 7730</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:39:51.011Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000407</udiDi>
    <basicUdiDi>B-04050598000407</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 6821</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:39:20.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000315</udiDi>
    <basicUdiDi>B-04050598000315</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 5601</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:39:10.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000308</udiDi>
    <basicUdiDi>B-04050598000308</basicUdiDi>
    <tradeName>IDK® Kynurenic Acid (KynA) ELISA</tradeName>
    <deviceName>IDK® Kynurenic Acid (KynA) 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 7735</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:39:08.525Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000049</udiDi>
    <basicUdiDi>B-04050598000049</basicUdiDi>
    <tradeName>GABA ELISA</tradeName>
    <deviceName>GABA 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 7012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:53.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-02B0024YP</udiDi>
    <basicUdiDi>B-02B0024YP</basicUdiDi>
    <tradeName>D-02B0024YP</tradeName>
    <deviceName>Serum amyloid A Reagent Kit</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3H001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:29:19.039Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850521006032</udiDi>
    <basicUdiDi>B-00850521006032</basicUdiDi>
    <tradeName>REDI-Dx</tradeName>
    <deviceName>Radiation Biodosimetry Test (REDI-Dx Test System)</deviceName>
    <manufacturerName>DxTerity Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029372</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>135488</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:09:48.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426021570</udiDi>
    <basicUdiDi>B-00816426021570</basicUdiDi>
    <tradeName>K-ASSAY KL-6 Calibrator (Ver.2)</tradeName>
    <deviceName>KL-6 Calibrator (Ver.2)</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-351C</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:39:39.771Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426021563</udiDi>
    <basicUdiDi>B-00816426021563</basicUdiDi>
    <tradeName>K-ASSAY KL-6 (Ver.2)</tradeName>
    <deviceName>KL-6 (Ver.2) Reagent</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-350</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:39:38.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426020689</udiDi>
    <basicUdiDi>B-00816426020689</basicUdiDi>
    <tradeName>K-ASSAY Ferritin Calibrator</tradeName>
    <deviceName>Ferritin Calibrator</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-094C</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:38:53.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984063744</udiDi>
    <basicUdiDi>69703416803205101J2</basicUdiDi>
    <tradeName>S100 (eCLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320509102</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T03:32:04.956Z</lastUpdated>
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  <row>
    <udiDi>06975984063751</udiDi>
    <basicUdiDi>69703416803205101J2</basicUdiDi>
    <tradeName>S100 (eCLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320509103</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T03:32:04.890Z</lastUpdated>
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  <row>
    <udiDi>06975984063768</udiDi>
    <basicUdiDi>69703416803205101J2</basicUdiDi>
    <tradeName>S100 (eCLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320509104</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T03:32:04.835Z</lastUpdated>
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    <udiDi>00380740157319</udiDi>
    <basicUdiDi>8436003070139X8</basicUdiDi>
    <tradeName>Quantia β2-Microglobulin</tradeName>
    <deviceName>Quantia β2-Microglobulin</deviceName>
    <manufacturerName>Biokit S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000002406</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6K39-02</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:20:44.500Z</lastUpdated>
  </row>
  <row>
    <udiDi>00380740151027</udiDi>
    <basicUdiDi>8436003070153X2</basicUdiDi>
    <tradeName>Alinity c β2-Microglobulin Standard</tradeName>
    <deviceName>Alinity c β2-Microglobulin Reagent Kit</deviceName>
    <manufacturerName>Biokit S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000002406</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01R0901</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:20:37.284Z</lastUpdated>
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    <udiDi>28058945153363</udiDi>
    <basicUdiDi>8058945151N3300R29</basicUdiDi>
    <tradeName>Evo Specific SPA</tradeName>
    <deviceName>Allergy SPA Recombinants - Allergia SPA Ricombinanti</deviceName>
    <manufacturerName>ABD SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000029729</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1N3300 G205</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:18:05.288Z</lastUpdated>
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</eudamedExport>