<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00847627006387</udiDi>
    <basicUdiDi>B-00847627006387</basicUdiDi>
    <tradeName>CD31 (PECAM-1)</tradeName>
    <deviceName>CD31 (PECAM-1)</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CM131C</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-01T17:40:12.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>00847627006370</udiDi>
    <basicUdiDi>B-00847627006370</basicUdiDi>
    <tradeName>CD31 (PECAM-1)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CM131A</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-01T17:40:00.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>00847627006332</udiDi>
    <basicUdiDi>B-00847627006332</basicUdiDi>
    <tradeName>CD10</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CM129CK</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-01T17:39:59.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>00847627006325</udiDi>
    <basicUdiDi>B-00847627006325</basicUdiDi>
    <tradeName>CD10</tradeName>
    <deviceName>CD10</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CM129BK</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-01T17:39:55.355Z</lastUpdated>
  </row>
  <row>
    <udiDi>00847627006318</udiDi>
    <basicUdiDi>B-00847627006318</basicUdiDi>
    <tradeName>CD10</tradeName>
    <deviceName>CD10</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CM129AK</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-01T17:39:54.559Z</lastUpdated>
  </row>
  <row>
    <udiDi>00847627006257</udiDi>
    <basicUdiDi>B-00847627006257</basicUdiDi>
    <tradeName>CA19-9</tradeName>
    <deviceName>CA19-9</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CM123A</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-01T17:39:53.757Z</lastUpdated>
  </row>
  <row>
    <udiDi>00847627005014</udiDi>
    <basicUdiDi>B-00847627005014</basicUdiDi>
    <tradeName>Breast Cocktail(CKHMW/p63+CK7/8/18)</tradeName>
    <deviceName>Breast Cocktail(CKHMW/p63+CK7/8/18)</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVI3203DSKG</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T17:39:52.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>00847627004222</udiDi>
    <basicUdiDi>B-00847627004222</basicUdiDi>
    <tradeName>CD103 (RM)</tradeName>
    <deviceName>CD103 (RM)</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>API3117AA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T17:39:48.952Z</lastUpdated>
  </row>
  <row>
    <udiDi>00847627003072</udiDi>
    <basicUdiDi>B-00847627003072</basicUdiDi>
    <tradeName>CD103 (RM)</tradeName>
    <deviceName>CD103 (RM)</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACI3117B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-01T17:39:48.149Z</lastUpdated>
  </row>
  <row>
    <udiDi>00847627003065</udiDi>
    <basicUdiDi>B-00847627003065</basicUdiDi>
    <tradeName>CD103 (RM)</tradeName>
    <deviceName>CD103 (RM)</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACI3117A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-01T17:39:47.349Z</lastUpdated>
  </row>
  <row>
    <udiDi>05414470815449</udiDi>
    <basicUdiDi>541447003155</basicUdiDi>
    <tradeName>Lumipulse G pTau 217 Plasma Immunoreaction Cartridges &lt;3x14T, CE&gt;</tradeName>
    <deviceName>Lumipulse G pTau 217 Plasma Immunoreaction Cartridges</deviceName>
    <manufacturerName>Fujirebio Europe N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000001792</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019017</emdnCode>
    <emdnDescription>PHOSPHORYLATED TAU (PTAU)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81544</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T17:16:10.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>05414470815456</udiDi>
    <basicUdiDi>541447003155</basicUdiDi>
    <tradeName>Lumipulse G pTau 217 Plasma Calibrators &lt;1x5C, CE&gt;</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fujirebio Europe N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000001792</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102019017</emdnCode>
    <emdnDescription>PHOSPHORYLATED TAU (PTAU)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81545</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T17:16:10.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>05414470815463</udiDi>
    <basicUdiDi>54144700375H</basicUdiDi>
    <tradeName>Lumipulse pTau 217 Plasma Controls &lt;2x2C, CE&gt;</tradeName>
    <deviceName>Lumipulse pTau 217 Plasma Controls</deviceName>
    <manufacturerName>Fujirebio Europe N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000001792</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81546</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T17:16:10.813Z</lastUpdated>
  </row>
  <row>
    <udiDi>06914329008651</udiDi>
    <basicUdiDi>B-06914329008651</basicUdiDi>
    <tradeName>06914329008651</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Yicheng Bioelectronics Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033130</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>122000114 132000001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-01T14:12:15.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>06914329008798</udiDi>
    <basicUdiDi>B-06914329008798</basicUdiDi>
    <tradeName>06914329008798</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Yicheng Bioelectronics Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033130</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060106</emdnCode>
    <emdnDescription>UREA TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Uric Acid Test Strips</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-01T14:12:15.007Z</lastUpdated>
  </row>
  <row>
    <udiDi>06914329008804</udiDi>
    <basicUdiDi>B-06914329008804</basicUdiDi>
    <tradeName>06914329008804</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Yicheng Bioelectronics Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033130</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060110</emdnCode>
    <emdnDescription>KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>124000020</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-01T14:12:14.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>06914329008811</udiDi>
    <basicUdiDi>B-06914329008811</basicUdiDi>
    <tradeName>06914329008811</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Yicheng Bioelectronics Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033130</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Model  mALB-1：125000007、Model  mALB-2：125000009、Model  mALB-3：125000008</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-01T14:12:14.959Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920234700221</udiDi>
    <basicUdiDi>69202347BRED002CL</basicUdiDi>
    <tradeName>Kit for determination of the DNA fragmentation level in spermatozoa (SCD method)</tradeName>
    <deviceName>Kit for determination of the DNA fragmentation level in spermatozoa (SCD method)</deviceName>
    <manufacturerName>BRED Life Science Technology Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000037518</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010302</emdnCode>
    <emdnDescription>ROMANOWSKY STAINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10 tests/kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T14:12:14.587Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250310703962</udiDi>
    <basicUdiDi>B-04250310703962</basicUdiDi>
    <tradeName>Anti-CCP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GA Generic Assays GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032990</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3665</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T10:58:16.328Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840140799996</udiDi>
    <basicUdiDi>B-00840140799996</basicUdiDi>
    <tradeName>Glutamine Synthetase</tradeName>
    <deviceName>Glutamine Synthetase</deviceName>
    <manufacturerName>Zeta Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000008650</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030709</emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z2668MP</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-01T09:10:18.652Z</lastUpdated>
  </row>
</eudamedExport>