<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>17090041920108</udiDi>
    <basicUdiDi>B-17090041920108</basicUdiDi>
    <tradeName>Seronorm® Human High</tradeName>
    <deviceName>Seronorm® Human High</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>203005</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:10:25.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>17090041920092</udiDi>
    <basicUdiDi>B-17090041920092</basicUdiDi>
    <tradeName>Seronorm® Human</tradeName>
    <deviceName>Seronorm® Human</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>200805</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:10:24.216Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065026245226</udiDi>
    <basicUdiDi>B-15065026245226</basicUdiDi>
    <tradeName>TruAna</tradeName>
    <deviceName>Chemistry Control</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050199</emdnCode>
    <emdnDescription>MULTICOMPONENT CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TA10011</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:37:34.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>10851290002482</udiDi>
    <basicUdiDi>B-10851290002482</basicUdiDi>
    <tradeName>RNA Medical® Full Range CO-Oximeter Control</tradeName>
    <deviceName>RNA Medical® Full Range CO-Oximeter Control -multi level</deviceName>
    <manufacturerName>Bionostics</manufacturerName>
    <manufacturerSrn>US-MF-000041075</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QC253</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:42:04.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>10851290002451</udiDi>
    <basicUdiDi>B-10851290002451</basicUdiDi>
    <tradeName>RNA Medical® Full Range CO-Oximeter Control -level 1</tradeName>
    <deviceName>RNA Medical® Full Range CO-Oximeter Control-level 1</deviceName>
    <manufacturerName>Bionostics</manufacturerName>
    <manufacturerSrn>US-MF-000041075</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QC253</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:42:00.360Z</lastUpdated>
  </row>
  <row>
    <udiDi>10851290002444</udiDi>
    <basicUdiDi>B-10851290002444</basicUdiDi>
    <tradeName>RNA Medical CC 527 Blood Gas/Electrolyte/CO-Oximeter Control</tradeName>
    <deviceName>RNA Medical CC 527 Blood Gas/Electrolyte/CO-Oximeter Control- Multi</deviceName>
    <manufacturerName>Bionostics</manufacturerName>
    <manufacturerSrn>US-MF-000041075</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC527</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:41:59.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>10851290002475</udiDi>
    <basicUdiDi>B-10851290002475</basicUdiDi>
    <tradeName>RNA Medical® Full Range CO-Oximeter Control -level 3</tradeName>
    <deviceName>RNA Medical QC 253 Full Range CO-Oximeter Control-level 3</deviceName>
    <manufacturerName>Bionostics</manufacturerName>
    <manufacturerSrn>US-MF-000041075</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QC253-level 3</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:41:58.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>10851290002468</udiDi>
    <basicUdiDi>B-10851290002468</basicUdiDi>
    <tradeName>RNA Medical QC 253 Full Range CO-Oximeter Control-level 2</tradeName>
    <deviceName>RNA Medical QC 253 Full Range CO-Oximeter Control-level 2</deviceName>
    <manufacturerName>Bionostics</manufacturerName>
    <manufacturerSrn>US-MF-000041075</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QC253-level 2</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:41:58.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>10851290002437</udiDi>
    <basicUdiDi>B-10851290002437</basicUdiDi>
    <tradeName>RNA Medical CC 527 Blood Gas/Electrolyte/CO-Oximeter Control- Level 3</tradeName>
    <deviceName>RNA Medical CC 527 Blood Gas/Electrolyte/CO-Oximeter Control- Level 3</deviceName>
    <manufacturerName>Bionostics</manufacturerName>
    <manufacturerSrn>US-MF-000041075</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC527-level 3</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:41:41.091Z</lastUpdated>
  </row>
  <row>
    <udiDi>10851290002420</udiDi>
    <basicUdiDi>B-10851290002420</basicUdiDi>
    <tradeName>RNA Medical CC 527 Blood Gas/Electrolyte/CO-Oximeter Control- Level 2</tradeName>
    <deviceName>RNA Medical CC 527 Blood Gas/Electrolyte/CO-Oximeter Control- Level 2</deviceName>
    <manufacturerName>Bionostics</manufacturerName>
    <manufacturerSrn>US-MF-000041075</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC527-level 2</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:41:40.305Z</lastUpdated>
  </row>
  <row>
    <udiDi>10851290002413</udiDi>
    <basicUdiDi>B-10851290002413</basicUdiDi>
    <tradeName>RNA Medical CC 527 Blood Gas/Electrolyte/CO-Oximeter Control- level 1</tradeName>
    <deviceName>RNA Medical CC 527 Blood Gas/Electrolyte/CO-Oximeter Control- level 1</deviceName>
    <manufacturerName>Bionostics</manufacturerName>
    <manufacturerSrn>US-MF-000041075</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC527-level 1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:41:39.489Z</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>08699015281812</udiDi>
    <basicUdiDi>B-08699015281812</basicUdiDi>
    <tradeName>HDL-LDL KALİBRATÖR (ARCAL LİPİT)</tradeName>
    <deviceName>HDL-LDL CALIBRATOR ( ARCAL LIPID)</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</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>01R95-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:12:54.098Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812526289</udiDi>
    <basicUdiDi>B-08681812526289</basicUdiDi>
    <tradeName>ÇOK BİLEŞENLİ KALİBRATÖR</tradeName>
    <deviceName>MULTICONSTITUENT CALIBRATOR</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</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>06R56-02</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:41:10.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-084360385825824H7</udiDi>
    <basicUdiDi>B-084360385825824H7</basicUdiDi>
    <tradeName>Contro-P, 4 x 5 mL</tradeName>
    <deviceName>Contro-P, 4 x 5 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</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>101-0253</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:30:01.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-084360385815817GX</udiDi>
    <basicUdiDi>B-084360385815817GX</basicUdiDi>
    <tradeName>Contro-N, 4 x 5 mL</tradeName>
    <deviceName>Contro-N, 4 x 5 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</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>101-0252</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:29:56.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-084360385385386H5</udiDi>
    <basicUdiDi>B-084360385385386H5</basicUdiDi>
    <tradeName>Contro-P, 20 x 5 mL</tradeName>
    <deviceName>Contro-P, 20 x 5 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</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>101-0084</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:29:06.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-084360385375379GV</udiDi>
    <basicUdiDi>B-084360385375379GV</basicUdiDi>
    <tradeName>Contro-N, 20 x 5 mL</tradeName>
    <deviceName>Contro-N, 20 x 5 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</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>101-0083</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:29:04.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435287102536</udiDi>
    <basicUdiDi>B-08435287102536</basicUdiDi>
    <tradeName>08435287102536</tradeName>
    <deviceName>AMMONIA/ETHANOL/CO2 CONTROL I/II</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</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>18064</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:41:58.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435287102529</udiDi>
    <basicUdiDi>B-08435287102529</basicUdiDi>
    <tradeName>08435287102529</tradeName>
    <deviceName>AMMONIA/ETHANOL/CO2 CONTROL I/II</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</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>18063</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:41:57.824Z</lastUpdated>
  </row>
</eudamedExport>