<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-106959NU</udiDi>
    <basicUdiDi>B-106959NU</basicUdiDi>
    <tradeName>A1C HD CONTROL</tradeName>
    <deviceName>A1C HD CONTROL</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>106959</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:48:07.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-106342MD</udiDi>
    <basicUdiDi>B-106342MD</basicUdiDi>
    <tradeName>OSMO STATION Control Solution Set</tradeName>
    <deviceName>OSMO STATION Control Solution Set</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>106342</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:38:09.067Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-105730MK</udiDi>
    <basicUdiDi>B-105730MK</basicUdiDi>
    <tradeName>CALIBRATOR 90</tradeName>
    <deviceName>CALIBRATOR 90</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105730</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:28:03.861Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-10282EX</udiDi>
    <basicUdiDi>B-10282EX</basicUdiDi>
    <tradeName>ClinChek® Plasma Control, lyophil., for Amino Acids (by Amino Acid Analyzer), Level I, II</tradeName>
    <deviceName>Plasma Control for Amino Acids (by Amino Acid Analyzer)</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050199</emdnCode>
    <emdnDescription>MULTICOMPONENT CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10282</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:58:05.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-10213EC</udiDi>
    <basicUdiDi>B-10213EC</basicUdiDi>
    <tradeName>ClinCal® Plasma Calibrator, lyophil., for Amino Acids (by Amino Acid Analyzer (AAA))</tradeName>
    <deviceName>Plasma Calibrator for Amino Acids (by Amino Acid Analyzer)</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10213</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:56:59.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-101714LR</udiDi>
    <basicUdiDi>B-101714LR</basicUdiDi>
    <tradeName>CALIBRATOR Lite</tradeName>
    <deviceName>CALIBRATOR Lite</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101714</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:48:10.689Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-100187776A</udiDi>
    <basicUdiDi>B-100187776A</basicUdiDi>
    <tradeName>Cascadion™ SM Immunosuppressants Panel Internal Standard</tradeName>
    <deviceName>Cascadion™ SM Immunosuppressants Panel Internal Standard</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10018777</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:36:00.623Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1001877566</udiDi>
    <basicUdiDi>B-1001877566</basicUdiDi>
    <tradeName>Cascadion™ SM Immunosuppressants Panel Control 3</tradeName>
    <deviceName>Cascadion™ SM Immunosuppressants Panel Control 3</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10018775</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:35:59.829Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-100187725Y</udiDi>
    <basicUdiDi>B-100187725Y</basicUdiDi>
    <tradeName>Cascadion™ SM Immunosuppressants Panel Calibrator Set</tradeName>
    <deviceName>Cascadion™ SM Immunosuppressants Panel Calibrator Set</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10018772</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:35:55.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-100187645Z</udiDi>
    <basicUdiDi>B-100187645Z</basicUdiDi>
    <tradeName>Cascadion™ SM 25-Hydroxy Vitamin D Internal Standard</tradeName>
    <deviceName>Cascadion™ SM 25-Hydroxy Vitamin D Internal Standard</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10018764</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:35:55.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1001877464</udiDi>
    <basicUdiDi>B-1001877464</basicUdiDi>
    <tradeName>Cascadion™ SM Immunosuppressants Panel Control 2</tradeName>
    <deviceName>Cascadion™ SM Immunosuppressants Panel Control 2</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10018774</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:35:54.228Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1001877362</udiDi>
    <basicUdiDi>B-1001877362</basicUdiDi>
    <tradeName>Cascadion™ SM Immunosuppressants Panel Control 1</tradeName>
    <deviceName>Cascadion™ SM Immunosuppressants Panel Control 1</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10018773</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:35:53.431Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-100187635X</udiDi>
    <basicUdiDi>B-100187635X</basicUdiDi>
    <tradeName>Cascadion™ SM 25-Hydroxy Vitamin D Control 3</tradeName>
    <deviceName>Cascadion™ SM 25-Hydroxy Vitamin D Control 3</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10018763</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:35:35.771Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-100187625V</udiDi>
    <basicUdiDi>B-100187625V</basicUdiDi>
    <tradeName>Cascadion™ SM 25-Hydroxy Vitamin D Control 2</tradeName>
    <deviceName>Cascadion™ SM 25-Hydroxy Vitamin D Control 2</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10018762</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:35:34.960Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-100187615T</udiDi>
    <basicUdiDi>B-100187615T</basicUdiDi>
    <tradeName>Cascadion™ SM 25-Hydroxy Vitamin D Control 1</tradeName>
    <deviceName>Cascadion™ SM 25-Hydroxy Vitamin D Control 1</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10018761</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:35:34.167Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-100187605R</udiDi>
    <basicUdiDi>B-100187605R</basicUdiDi>
    <tradeName>Cascadion™ SM 25-Hydroxy Vitamin D Calibrator Set</tradeName>
    <deviceName>Cascadion™ SM 25-Hydroxy Vitamin D Calibrator Set</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10018760</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:35:33.376Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421902348099</udiDi>
    <basicUdiDi>B-09421902348099</basicUdiDi>
    <tradeName>extendSURE™ HbA1c Liquid Controls</tradeName>
    <deviceName>extendSURE™ HbA1c Liquid Controls</deviceName>
    <manufacturerName>Canterbury Scientific Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000001778</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B12397</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:51:56.512Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421902348075</udiDi>
    <basicUdiDi>B-09421902348075</basicUdiDi>
    <tradeName>extendSURETM Haemoglobin A1c Lyophilised Controls</tradeName>
    <deviceName>extendSURETM Haemoglobin A1c Lyophilised Controls</deviceName>
    <manufacturerName>Canterbury Scientific Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000001778</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB710SBAr</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:51:54.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421902348006</udiDi>
    <basicUdiDi>B-09421902348006</basicUdiDi>
    <tradeName>extendSURE™ HbA1c Liquid Controls</tradeName>
    <deviceName>extendSURE™ HbA1c Liquid Controls</deviceName>
    <manufacturerName>Canterbury Scientific Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000001778</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B12396</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:51:50.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809446080964</udiDi>
    <basicUdiDi>B-08809446080964</basicUdiDi>
    <tradeName>08809446080964</tradeName>
    <deviceName>careSTART™ Total Bilirubin Biosensor Control</deviceName>
    <manufacturerName>WELLS BIO, INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000031789</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050203</emdnCode>
    <emdnDescription>BILIRUBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCB-N05082</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:09:57.518Z</lastUpdated>
  </row>
</eudamedExport>