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<eudamedExport entity="devices">
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    <udiDi>06975519630014</udiDi>
    <basicUdiDi>B-06975519630014</basicUdiDi>
    <tradeName>Hemoglobin Test Strips</tradeName>
    <deviceName>Hemoglobin Test Strips</deviceName>
    <manufacturerName>Hangzhou Bosure Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000003001</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BS-101-1</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:32:29.848Z</lastUpdated>
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  <row>
    <udiDi>04050598009516</udiDi>
    <basicUdiDi>B-04050598009516</basicUdiDi>
    <tradeName>PreventID® Haemo/HaptOccult</tradeName>
    <deviceName>PreventID® Haemo/HaptOccult</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KST40112TP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:48:26.901Z</lastUpdated>
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  <row>
    <udiDi>04050598008960</udiDi>
    <basicUdiDi>B-04050598008960</basicUdiDi>
    <tradeName>PreventID® CC</tradeName>
    <deviceName>PreventID® CC</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KST40110GP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:48:01.286Z</lastUpdated>
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  <row>
    <udiDi>04050598008205</udiDi>
    <basicUdiDi>B-04050598008205</basicUdiDi>
    <tradeName>PreventID® CC</tradeName>
    <deviceName>PreventID® CC</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KST40110TP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:01.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598008199</udiDi>
    <basicUdiDi>B-04050598008199</basicUdiDi>
    <tradeName>PreventID® CC</tradeName>
    <deviceName>PreventID® CC</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KST40110EP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:00.377Z</lastUpdated>
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  <row>
    <udiDi>04050598003606</udiDi>
    <basicUdiDi>B-04050598003606</basicUdiDi>
    <tradeName>IDK® Hemoglobin (1-point-calibration) ELISA</tradeName>
    <deviceName>IDK® Hemoglobin (1-point-calibration) ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 7836D.20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:43:12.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598003583</udiDi>
    <basicUdiDi>B-04050598003583</basicUdiDi>
    <tradeName>IDK® Hemoglobin (human) ELISA</tradeName>
    <deviceName>IDK® Hemoglobin (human) ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 7816D.20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:43:11.296Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598001626</udiDi>
    <basicUdiDi>B-04050598001626</basicUdiDi>
    <tradeName>IDK® Hemoglobin/Haptoglobin Complex ELISA</tradeName>
    <deviceName>IDK® Hemoglobin/Haptoglobin Complex ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 7817D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:40:55.092Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000742</udiDi>
    <basicUdiDi>B-04050598000742</basicUdiDi>
    <tradeName>IDK® Hemoglobin (1-point-calibration) ELISA</tradeName>
    <deviceName>IDK® Hemoglobin (1-point-calibration) ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 7836D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:40:06.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000674</udiDi>
    <basicUdiDi>B-04050598000674</basicUdiDi>
    <tradeName>IDK® Hemoglobin (human) ELISA</tradeName>
    <deviceName>IDK® Hemoglobin (human) ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 7816D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:39:59.816Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000421</udiDi>
    <basicUdiDi>B-04050598000421</basicUdiDi>
    <tradeName>IDK® Hemoglobin/Haptoglobin Complex (1-point-calibration) ELISA</tradeName>
    <deviceName>IDK® Hemoglobin/Haptoglobin Complex (1-point-calibration) ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 7837D.20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:39:22.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598000414</udiDi>
    <basicUdiDi>B-04050598000414</basicUdiDi>
    <tradeName>IDK® Hemoglobin/Haptoglobin Complex (1-point-calibration) ELISA</tradeName>
    <deviceName>IDK® Hemoglobin/Haptoglobin Complex (1-point-calibration) ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 7837D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:39:21.334Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760356010159</udiDi>
    <basicUdiDi>B-03760356010159</basicUdiDi>
    <tradeName>NovaGray RILA Legacy Breast</tradeName>
    <deviceName>NovaGray RILA Legacy Breast</deviceName>
    <manufacturerName>NovaGray</manufacturerName>
    <manufacturerSrn>FR-MF-000009808</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010604</emdnCode>
    <emdnDescription>WHITE BLOOD CELLS (WBC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NovaGray RILA Legacy Breast</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:19:10.997Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760356010142</udiDi>
    <basicUdiDi>B-03760356010142</basicUdiDi>
    <tradeName>NovaGray RILA Legacy Prostate</tradeName>
    <deviceName>NovaGray RILA Legacy Prostate</deviceName>
    <manufacturerName>NovaGray</manufacturerName>
    <manufacturerSrn>FR-MF-000009808</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010604</emdnCode>
    <emdnDescription>WHITE BLOOD CELLS (WBC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NovaGray RILA Legacy Prostate</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:19:09.396Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760356010128</udiDi>
    <basicUdiDi>B-03760356010128</basicUdiDi>
    <tradeName>NovaGray RILA Gray Legacy Breast</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NovaGray</manufacturerName>
    <manufacturerSrn>FR-MF-000009808</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010604</emdnCode>
    <emdnDescription>WHITE BLOOD CELLS (WBC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NovaGray RILA Gray Legacy Breast</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:19:06.984Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760356010036</udiDi>
    <basicUdiDi>B-03760356010036</basicUdiDi>
    <tradeName>NovaGray RILA Breast</tradeName>
    <deviceName>NovaGray RILA Breast</deviceName>
    <manufacturerName>NovaGray</manufacturerName>
    <manufacturerSrn>FR-MF-000009808</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010604</emdnCode>
    <emdnDescription>WHITE BLOOD CELLS (WBC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NovaGray RILA Breast</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:19:05.385Z</lastUpdated>
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  <row>
    <udiDi>03760356010029</udiDi>
    <basicUdiDi>B-03760356010029</basicUdiDi>
    <tradeName>NovaGray RILA Prostate</tradeName>
    <deviceName>NovaGray RILA Prostate</deviceName>
    <manufacturerName>NovaGray</manufacturerName>
    <manufacturerSrn>FR-MF-000009808</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010604</emdnCode>
    <emdnDescription>WHITE BLOOD CELLS (WBC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NovaGray RILA Prostate</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:19:04.594Z</lastUpdated>
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    <udiDi>10888234000488</udiDi>
    <basicUdiDi>88823401W01030399A0000249</basicUdiDi>
    <tradeName>Platelet Wash and Storage Solution</tradeName>
    <deviceName>Platelet Wash and Storage Solution</deviceName>
    <manufacturerName>Immucor, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011568</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007083</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010605</emdnCode>
    <emdnDescription>PLATELETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0005035</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:08:18.522Z</lastUpdated>
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    <udiDi>06978848020006</udiDi>
    <basicUdiDi>697884802SA1RUD</basicUdiDi>
    <tradeName>Kit for Morphology Analyzer</tradeName>
    <deviceName>Kit for Morphology Analyzer</deviceName>
    <manufacturerName>Seamaty Diagnostic Technology (Chengdu) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047425</manufacturerSrn>
    <authorisedRepresentativeName>GRZAN GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000038821</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010699</emdnCode>
    <emdnDescription>HAEMATOLOGY RAPID TESTS &amp; POINT OF CARE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MD10668</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:05:29.737Z</lastUpdated>
  </row>
  <row>
    <udiDi>06939663973106</udiDi>
    <basicUdiDi>B-06939663973106</basicUdiDi>
    <tradeName>Hemoglobin Test Strip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sejoy Biomedical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008447</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HS-101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:04:12.535Z</lastUpdated>
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