<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-8916CK</udiDi>
    <basicUdiDi>B-8916CK</basicUdiDi>
    <tradeName>ClinChek® Hemoglobin Control (low), lyophil., Level I, II, III, with Reconstitution Solution R</tradeName>
    <deviceName>Hemoglobin Control with Reconstitution Solution R</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>8916</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:44:30.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8843CH</udiDi>
    <basicUdiDi>B-8843CH</basicUdiDi>
    <tradeName>ClinChek® Whole Blood Control, lyophilised, for Trace Elements Level I, II, III</tradeName>
    <deviceName>Whole Blood Controls for Trace Elements</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>8843</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:27:49.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8816CE</udiDi>
    <basicUdiDi>B-8816CE</basicUdiDi>
    <tradeName>ClinChek® Hemoglobin Control, lyophil., Level I, II, III, with Reconstitution Solution R</tradeName>
    <deviceName>Hemoglobin Control with Reconstitution Solution R</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>8816</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:27:47.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77966KP</udiDi>
    <basicUdiDi>B-77966KP</basicUdiDi>
    <tradeName>SPOTCHEM D Control</tradeName>
    <deviceName>SPOTCHEM D 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>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>77966</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:25:21.177Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77043HW</udiDi>
    <basicUdiDi>B-77043HW</basicUdiDi>
    <tradeName>SPOTCHEM CALIBRATION CHECK</tradeName>
    <deviceName>SPOTCHEM CALIBRATION CHECK</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>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>77043</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:19:20.888Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-267.000.005EB</udiDi>
    <basicUdiDi>B-267.000.005EB</basicUdiDi>
    <tradeName>Eurotrol epoc Calibration Verification Fluids</tradeName>
    <deviceName>Eurotrol epoc Calibration Verification Fluids</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>267.000.005</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:48:21.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-266.006.010FF</udiDi>
    <basicUdiDi>B-266.006.010FF</basicUdiDi>
    <tradeName>Eurotrol epoc GAS-ISE Metabolites Level 6</tradeName>
    <deviceName>Eurotrol epoc GAS-ISE Metabolites Level 6</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>266.006.010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:48:18.767Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-266.003.010EE</udiDi>
    <basicUdiDi>B-266.003.010EE</basicUdiDi>
    <tradeName>Eurotrol epoc GAS-ISE Metabolites Level 3</tradeName>
    <deviceName>Eurotrol epoc GAS-ISE Metabolites Level 3</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>266.003.010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:48:16.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-266.002.010E3</udiDi>
    <basicUdiDi>B-266.002.010E3</basicUdiDi>
    <tradeName>Eurotrol epoc GAS-ISE Metabolites Level 2</tradeName>
    <deviceName>Eurotrol epoc GAS-ISE Metabolites Level 2</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>266.002.010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:48:14.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-266.001.010DQ</udiDi>
    <basicUdiDi>B-266.001.010DQ</basicUdiDi>
    <tradeName>Eurotrol epoc GAS-ISE Metabolites Level 1</tradeName>
    <deviceName>Eurotrol epoc GAS-ISE Metabolites Level 1</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>266.001.010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:48:13.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>17090041922157</udiDi>
    <basicUdiDi>B-17090041922157</basicUdiDi>
    <tradeName>Seronorm® Immunoprotein Liq L-2</tradeName>
    <deviceName>Seronorm® Immunoprotein Liq L-2</deviceName>
    <manufacturerName>SERO AS</manufacturerName>
    <manufacturerSrn>NO-MF-000012954</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>214505</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:12:06.778Z</lastUpdated>
  </row>
  <row>
    <udiDi>17090041922140</udiDi>
    <basicUdiDi>B-17090041922140</basicUdiDi>
    <tradeName>Seronorm® Immunoprotein Liq L-1</tradeName>
    <deviceName>Seronorm® Immunoprotein Liq L-1</deviceName>
    <manufacturerName>SERO AS</manufacturerName>
    <manufacturerSrn>NO-MF-000012954</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>214405</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:12:05.983Z</lastUpdated>
  </row>
  <row>
    <udiDi>17090041921778</udiDi>
    <basicUdiDi>B-17090041921778</basicUdiDi>
    <tradeName>Autonorm® Clin Chem Liq L-2</tradeName>
    <deviceName>Autonorm® Clin Chem Liq L-2</deviceName>
    <manufacturerName>SERO AS</manufacturerName>
    <manufacturerSrn>NO-MF-000012954</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>202115</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:11:49.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>17090041921761</udiDi>
    <basicUdiDi>B-17090041921761</basicUdiDi>
    <tradeName>Autonorm® Clin Chem Liq L-1</tradeName>
    <deviceName>Autonorm® Clin Chem Liq L-1</deviceName>
    <manufacturerName>SERO AS</manufacturerName>
    <manufacturerSrn>NO-MF-000012954</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>201915</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:11:48.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>17090041921785</udiDi>
    <basicUdiDi>B-17090041921785</basicUdiDi>
    <tradeName>Autonorm® Clin Chem Liq L-3</tradeName>
    <deviceName>Autonorm® Clin Chem Liq L-3</deviceName>
    <manufacturerName>SERO AS</manufacturerName>
    <manufacturerSrn>NO-MF-000012954</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>202215</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:11:47.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>17090041920580</udiDi>
    <basicUdiDi>B-17090041920580</basicUdiDi>
    <tradeName>Seronorm® Urine L-2</tradeName>
    <deviceName>Seronorm® Urine L-2</deviceName>
    <manufacturerName>SERO AS</manufacturerName>
    <manufacturerSrn>NO-MF-000012954</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>208605</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:11:27.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>17090041920573</udiDi>
    <basicUdiDi>B-17090041920573</basicUdiDi>
    <tradeName>Seronorm® Urine L-1</tradeName>
    <deviceName>Seronorm® Urine L-1</deviceName>
    <manufacturerName>SERO AS</manufacturerName>
    <manufacturerSrn>NO-MF-000012954</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>208505</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:11:23.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>17090041920160</udiDi>
    <basicUdiDi>B-17090041920160</basicUdiDi>
    <tradeName>Seronorm® Immunoprotein Lyo L-2</tradeName>
    <deviceName>Seronorm® Immunoprotein Lyo L-2</deviceName>
    <manufacturerName>SERO AS</manufacturerName>
    <manufacturerSrn>NO-MF-000012954</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>202905</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:10:45.091Z</lastUpdated>
  </row>
  <row>
    <udiDi>17090041920153</udiDi>
    <basicUdiDi>B-17090041920153</basicUdiDi>
    <tradeName>Seronorm® Immunoprotein Lyo L-1</tradeName>
    <deviceName>Seronorm® Immunoprotein Lyo L-1</deviceName>
    <manufacturerName>SERO AS</manufacturerName>
    <manufacturerSrn>NO-MF-000012954</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>202805</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:10:44.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>17090041920115</udiDi>
    <basicUdiDi>B-17090041920115</basicUdiDi>
    <tradeName>Seronorm® Paediatric</tradeName>
    <deviceName>Seronorm® Paediatric</deviceName>
    <manufacturerName>SERO AS</manufacturerName>
    <manufacturerSrn>NO-MF-000012954</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>208005</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:10:25.819Z</lastUpdated>
  </row>
</eudamedExport>