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<eudamedExport entity="devices">
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    <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>
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  <row>
    <udiDi>D-155.005.002CJ</udiDi>
    <basicUdiDi>B-155.005.002CJ</basicUdiDi>
    <tradeName>GlucoTrol-NG Level 5</tradeName>
    <deviceName>GlucoTrol-NG Level 5</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>155.005.002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:47:28.275Z</lastUpdated>
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    <udiDi>D-155.004.002C7</udiDi>
    <basicUdiDi>B-155.004.002C7</basicUdiDi>
    <tradeName>GlucoTrol-NG Level 4</tradeName>
    <deviceName>GlucoTrol-NG Level 4</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>155.004.002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:47:27.470Z</lastUpdated>
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    <udiDi>D-155.003.002BU</udiDi>
    <basicUdiDi>B-155.003.002BU</basicUdiDi>
    <tradeName>GlucoTrol-NG Level 3</tradeName>
    <deviceName>GlucoTrol-NG 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>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>155.003.002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:47:23.476Z</lastUpdated>
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  <row>
    <udiDi>D-155.002.002BH</udiDi>
    <basicUdiDi>B-155.002.002BH</basicUdiDi>
    <tradeName>GlucoTrol-NG Level 2</tradeName>
    <deviceName>GlucoTrol-NG 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>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>155.002.002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:47:22.671Z</lastUpdated>
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  <row>
    <udiDi>D-155.001.002B6</udiDi>
    <basicUdiDi>B-155.001.002B6</basicUdiDi>
    <tradeName>GlucoTrol Level 1</tradeName>
    <deviceName>GlucoTrol-NG 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>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>155.001.002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:47:21.876Z</lastUpdated>
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  <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>
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  <row>
    <udiDi>15065023763976</udiDi>
    <basicUdiDi>B-15065023763976</basicUdiDi>
    <tradeName>TruLyta</tradeName>
    <deviceName>Electrolyte 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>W0101050204</emdnCode>
    <emdnDescription>ELECTROLYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TL10003</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:36:48.416Z</lastUpdated>
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  <row>
    <udiDi>D-146.005.002CC</udiDi>
    <basicUdiDi>B-146.005.002CC</basicUdiDi>
    <tradeName>GlucoTrol-NG Level 5</tradeName>
    <deviceName>GlucoTrol-NG Level 5</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>146.005.002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:17:57.784Z</lastUpdated>
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  <row>
    <udiDi>D-146.004.002BZ</udiDi>
    <basicUdiDi>B-146.004.002BZ</basicUdiDi>
    <tradeName>GlucoTrol-NG Level 4</tradeName>
    <deviceName>GlucoTrol-NG Level 4</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>146.004.002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:17:56.978Z</lastUpdated>
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  <row>
    <udiDi>D-146.003.002BN</udiDi>
    <basicUdiDi>B-146.003.002BN</basicUdiDi>
    <tradeName>GlucoTrol-NG Level 3</tradeName>
    <deviceName>GlucoTrol-NG 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>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>146.003.002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:17:56.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-146.002.002BB</udiDi>
    <basicUdiDi>B-146.002.002BB</basicUdiDi>
    <tradeName>GlucoTrol-NG Level 2</tradeName>
    <deviceName>GlucoTrol-NG 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>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>146.002.002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:17:52.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-146.001.002AY</udiDi>
    <basicUdiDi>B-146.001.002AY</basicUdiDi>
    <tradeName>GlucoTrol-NG Level 1</tradeName>
    <deviceName>GlucoTrol-NG 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>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>146.001.002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:17:51.378Z</lastUpdated>
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  <row>
    <udiDi>D-108931NL</udiDi>
    <basicUdiDi>B-108931NL</basicUdiDi>
    <tradeName>ADAMS A1C CONTROL</tradeName>
    <deviceName>ADAMS A1C 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>108931</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:43:34.529Z</lastUpdated>
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  <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>
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    <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>
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    <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>
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    <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>
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    <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>
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  <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>
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