<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04987274139352</udiDi>
    <basicUdiDi>4987274W0102039013HBR02YB</basicUdiDi>
    <tradeName>FIT Hemoglobin AA01</tradeName>
    <deviceName>FIT Hemoglobin AA01</deviceName>
    <manufacturerName>Alfresa Pharma Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000008778</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039013</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>913935</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:32:08.335Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987274108693</udiDi>
    <basicUdiDi>4987274W0102039013HBR01Y9</basicUdiDi>
    <tradeName>FIT Hemoglobin NS-Prime</tradeName>
    <deviceName>FIT Hemoglobin NS-Prime</deviceName>
    <manufacturerName>Alfresa Pharma Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000008778</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039013</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>910869</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:31:54.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987026207339</udiDi>
    <basicUdiDi>4987026TD-OCLSZW</basicUdiDi>
    <tradeName>OC-Light™ S FIT Test Strips</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039013</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PC52</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:31:40.324Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987026117294</udiDi>
    <basicUdiDi>4987026TD-OCHBYG</basicUdiDi>
    <tradeName>OC-SENSOR FIT Buffer (for OC-SENSOR io, Micro)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039013</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PH46</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:31:34.749Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260157632219</udiDi>
    <basicUdiDi>426015763867BFreePSAKXXEQ</basicUdiDi>
    <tradeName>B·R·A·H·M·S Free PSA KRYPTOR</tradeName>
    <deviceName>B·R·A·H·M·S Free PSA KRYPTOR</deviceName>
    <manufacturerName>B·R·A·H·M·S GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026030</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>867050N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:37:48.862Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260157632127</udiDi>
    <basicUdiDi>426015763839BCgAIIK00XXNL</basicUdiDi>
    <tradeName>B·R·A·H·M·S CgA II KRYPTOR</tradeName>
    <deviceName>B·R·A·H·M·S CgA II KRYPTOR</deviceName>
    <manufacturerName>B·R·A·H·M·S GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026030</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039014</emdnCode>
    <emdnDescription>CHROMOGRANIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>839050N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:34:15.275Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260157631984</udiDi>
    <basicUdiDi>426015763821BNSEK0000XXTW</basicUdiDi>
    <tradeName>B·R·A·H·M·S NSE KRYPTOR</tradeName>
    <deviceName>B·R·A·H·M·S NSE KRYPTOR</deviceName>
    <manufacturerName>B·R·A·H·M·S GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026030</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039007</emdnCode>
    <emdnDescription>NEURON SPECIFIC ENOLASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>821050N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:34:07.260Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260157631953</udiDi>
    <basicUdiDi>426015763817BCEAK0000XXB6</basicUdiDi>
    <tradeName>B·R·A·H·M·S CEA KRYPTOR</tradeName>
    <deviceName>B·R·A·H·M·S CEA KRYPTOR</deviceName>
    <manufacturerName>B·R·A·H·M·S GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026030</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>817100N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:34:02.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260157631946</udiDi>
    <basicUdiDi>426015763816BAFPK0000XXHT</basicUdiDi>
    <tradeName>B·R·A·H·M·S AFP KRYPTOR</tradeName>
    <deviceName>B·R·A·H·M·S AFP KRYPTOR</deviceName>
    <manufacturerName>B·R·A·H·M·S GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026030</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>816075N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:34:01.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260157631922</udiDi>
    <basicUdiDi>426015763812BSCCK0000XXKM</basicUdiDi>
    <tradeName>B·R·A·H·M·S SCC KRYPTOR</tradeName>
    <deviceName>B·R·A·H·M·S SCC KRYPTOR</deviceName>
    <manufacturerName>B·R·A·H·M·S GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026030</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030116</emdnCode>
    <emdnDescription>SQUAMOUS CELL CARCINOMA ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>812050N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:34:00.866Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260157631908</udiDi>
    <basicUdiDi>426015763810BTotaPSAKXXHJ</basicUdiDi>
    <tradeName>B·R·A·H·M·S Total PSA KRYPTOR</tradeName>
    <deviceName>B·R·A·H·M·S Total PSA KRYPTOR</deviceName>
    <manufacturerName>B·R·A·H·M·S GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026030</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>810100N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:33:56.060Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260157631885</udiDi>
    <basicUdiDi>426015763808BCA15-3K0XXRH</basicUdiDi>
    <tradeName>B·R·A·H·M·S CA 15-3 KRYPTOR</tradeName>
    <deviceName>B·R·A·H·M·S CA 15-3 KRYPTOR</deviceName>
    <manufacturerName>B·R·A·H·M·S GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026030</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>808075N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:33:54.453Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260157631878</udiDi>
    <basicUdiDi>426015763807BCA19-9K0XXUJ</basicUdiDi>
    <tradeName>B·R·A·H·M·S CA 19-9 KRYPTOR</tradeName>
    <deviceName>B·R·A·H·M·S CA 19-9 KRYPTOR</deviceName>
    <manufacturerName>B·R·A·H·M·S GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026030</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>807100N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:33:53.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260157631861</udiDi>
    <basicUdiDi>426015763805BCA125IIKXX2M</basicUdiDi>
    <tradeName>B·R·A·H·M·S CA 125 II KRYPTOR</tradeName>
    <deviceName>B·R·A·H·M·S CA 125 II KRYPTOR</deviceName>
    <manufacturerName>B·R·A·H·M·S GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026030</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030106</emdnCode>
    <emdnDescription>CANCER ANTIGEN 125</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805075N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:33:49.658Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026065256</udiDi>
    <basicUdiDi>357302BUDI000244T8</basicUdiDi>
    <tradeName>VIDAS® FPSA</tradeName>
    <deviceName>VIDAS® FPSA</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</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>30440</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:48:47.461Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026065126</udiDi>
    <basicUdiDi>357302BUDI000240SY</basicUdiDi>
    <tradeName>VIDAS® CA 19-9™</tradeName>
    <deviceName>VIDAS® CA 19-9™</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30427</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:48:43.461Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026064990</udiDi>
    <basicUdiDi>357302BUDI000236T9</basicUdiDi>
    <tradeName>VIDAS® AFP</tradeName>
    <deviceName>VIDAS® AFP</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30413</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:48:41.861Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590218690</udiDi>
    <basicUdiDi>150995905CA19-9IRMARN</basicUdiDi>
    <tradeName>IRMA CA 19-9 antigen</tradeName>
    <deviceName>IRMA CA 19-9 antigen</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM3151, B64313</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:45:19.270Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590217730</udiDi>
    <basicUdiDi>150995905IM25205L</basicUdiDi>
    <tradeName>PSA free IRMA KIT</tradeName>
    <deviceName>PSA free IRMA KIT</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</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>IM2520</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:45:04.073Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590217402</udiDi>
    <basicUdiDi>150995905CA15-3IRMAMG</basicUdiDi>
    <tradeName>IRMA MUC-1 gene associated antigen (CA 15-3)</tradeName>
    <deviceName>IRMA MUC-1 gene associated antigen (CA 15-3)</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM2397</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:44:34.391Z</lastUpdated>
  </row>
</eudamedExport>