<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00847627007865</udiDi>
    <basicUdiDi>B-00847627007865</basicUdiDi>
    <tradeName>Calretinin</tradeName>
    <deviceName>Calretinin</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>CP092A</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-01T17:40:19.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>00847627007551</udiDi>
    <basicUdiDi>B-00847627007551</basicUdiDi>
    <tradeName>BOB-1</tradeName>
    <deviceName>BOB-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>CM418B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-01T17:40:18.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>00847627007544</udiDi>
    <basicUdiDi>B-00847627007544</basicUdiDi>
    <tradeName>BOB-1</tradeName>
    <deviceName>BOB-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>CM418A</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-01T17:40:17.831Z</lastUpdated>
  </row>
  <row>
    <udiDi>00847627007131</udiDi>
    <basicUdiDi>B-00847627007131</basicUdiDi>
    <tradeName>BRCA-1</tradeName>
    <deviceName>BRCA-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>CM345B</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-01T17:40:17.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>00847627007124</udiDi>
    <basicUdiDi>B-00847627007124</basicUdiDi>
    <tradeName>BRCA-1</tradeName>
    <deviceName>BRCA-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>CM345A</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T17:40:13.023Z</lastUpdated>
  </row>
  <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>++B261CANB43009F</udiDi>
    <basicUdiDi>B-++B261CANB43009F</basicUdiDi>
    <tradeName>++B261CANB43009F</tradeName>
    <deviceName>Β2-Microglobulin ELISA Kit</deviceName>
    <manufacturerName>Diagnostics Biochem Canada Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000032449</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CAN-B-4300</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:39:44.000Z</lastUpdated>
  </row>
  <row>
    <udiDi>17350066140593</udiDi>
    <basicUdiDi>7350066140599R</basicUdiDi>
    <tradeName>CanAg Glypican-3 EIA</tradeName>
    <deviceName>CanAg Glypican-3 EIA</deviceName>
    <manufacturerName>Fujirebio Diagnostics AB</manufacturerName>
    <manufacturerSrn>SE-MF-000007811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030199</emdnCode>
    <emdnDescription>CANCER ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>503-10</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:24:22.293Z</lastUpdated>
  </row>
  <row>
    <udiDi>17350066140302</udiDi>
    <basicUdiDi>7350066140308Z</basicUdiDi>
    <tradeName>HE4 EIA</tradeName>
    <deviceName>HE4 EIA</deviceName>
    <manufacturerName>Fujirebio Diagnostics AB</manufacturerName>
    <manufacturerSrn>SE-MF-000007811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030119</emdnCode>
    <emdnDescription>HUMAN EPIDIDYMIS PROTEIN 4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>404-10</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:24:17.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>17350066140203</udiDi>
    <basicUdiDi>7350066140208W</basicUdiDi>
    <tradeName>CanAg Free PSA EIA</tradeName>
    <deviceName>CanAg Free PSA EIA</deviceName>
    <manufacturerName>Fujirebio Diagnostics AB</manufacturerName>
    <manufacturerSrn>SE-MF-000007811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030114</emdnCode>
    <emdnDescription>FREE PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>350-10</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:15:44.862Z</lastUpdated>
  </row>
  <row>
    <udiDi>17350066140173</udiDi>
    <basicUdiDi>73500661401799</basicUdiDi>
    <tradeName>CanAg PSA EIA</tradeName>
    <deviceName>CanAg PSA EIA</deviceName>
    <manufacturerName>Fujirebio Diagnostics AB</manufacturerName>
    <manufacturerSrn>SE-MF-000007811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>340-10</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:15:44.072Z</lastUpdated>
  </row>
</eudamedExport>