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<eudamedExport entity="devices">
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    <udiDi>00816784020178</udiDi>
    <basicUdiDi>B-00816784020178</basicUdiDi>
    <tradeName>ACCURUN 40 Anti-Measles, Mumps, Rubella, VZV Positive Control Series 5000</tradeName>
    <deviceName>ACCURUN 40 Anti-Measles, Mumps, Rubella, VZV Positive Control Series 5000</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080899</emdnCode>
    <emdnDescription>CONTROLS - INF. IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000-0039</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:40:43.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020154</udiDi>
    <basicUdiDi>B-00816784020154</basicUdiDi>
    <tradeName>ACCURUN 30 EBV IgG Positive Control</tradeName>
    <deviceName>ACCURUN 30 EBV IgG Positive Control</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000-0037</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:40:41.455Z</lastUpdated>
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  <row>
    <udiDi>00816784020161</udiDi>
    <basicUdiDi>B-00816784020161</basicUdiDi>
    <tradeName>ACCURUN 31 EBV IgM Positive Control</tradeName>
    <deviceName>ACCURUN 31 EBV IgM Positive Control</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000-0038</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:40:39.859Z</lastUpdated>
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  <row>
    <udiDi>00816784020130</udiDi>
    <basicUdiDi>B-00816784020130</basicUdiDi>
    <tradeName>ACCURUN 25 ToRCH IgG Positive Control S5000</tradeName>
    <deviceName>ACCURUN 25 ToRCH IgG Positive Control S5000</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000-0034</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:40:39.060Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020147</udiDi>
    <basicUdiDi>B-00816784020147</basicUdiDi>
    <tradeName>ACCURUN 26 ToRC IgM Positive Control Series 5000</tradeName>
    <deviceName>ACCURUN 26 ToRC IgM Positive Control Series 5000</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000-0035</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:40:36.659Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020116</udiDi>
    <basicUdiDi>B-00816784020116</basicUdiDi>
    <tradeName>A21 Series 2000 CE</tradeName>
    <deviceName>A21 Series 2000 CE</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000-0031</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:40:21.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020079</udiDi>
    <basicUdiDi>B-00816784020079</basicUdiDi>
    <tradeName>Accurun 2 Series 2700</tradeName>
    <deviceName>Accurun 2 Series 2700</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000-0023</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:40:19.799Z</lastUpdated>
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  <row>
    <udiDi>00816784020062</udiDi>
    <basicUdiDi>B-00816784020062</basicUdiDi>
    <tradeName>A1 Series 5600</tradeName>
    <deviceName>A1 Series 5600</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000-0018</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:40:19.006Z</lastUpdated>
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  <row>
    <udiDi>00816784020055</udiDi>
    <basicUdiDi>B-00816784020055</basicUdiDi>
    <tradeName>A1 Series 4400</tradeName>
    <deviceName>A1 Series 4400</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000-0010</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:40:17.403Z</lastUpdated>
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  <row>
    <udiDi>00816784020048</udiDi>
    <basicUdiDi>B-00816784020048</basicUdiDi>
    <tradeName>A1 Series 4000</tradeName>
    <deviceName>A1 Series 4000</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000-0008</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:40:15.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020031</udiDi>
    <basicUdiDi>B-00816784020031</basicUdiDi>
    <tradeName>A1 Series 2500</tradeName>
    <deviceName>A1 Series 2500</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000-0002</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:40:12.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816784020024</udiDi>
    <basicUdiDi>B-00816784020024</basicUdiDi>
    <tradeName>A1 Series 2400</tradeName>
    <deviceName>A1 Series 2400</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000-0001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:40:11.792Z</lastUpdated>
  </row>
  <row>
    <udiDi>09352224001396</udiDi>
    <basicUdiDi>935222409500725</basicUdiDi>
    <tradeName>Positive Control HSV/VZV/TP</tradeName>
    <deviceName>Positive Control HSV/VZV/TP</deviceName>
    <manufacturerName>SpeeDx Pty. Ltd.</manufacturerName>
    <manufacturerSrn>AU-MF-000016649</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>95007</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:07:22.368Z</lastUpdated>
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  <row>
    <udiDi>09352224001266</udiDi>
    <basicUdiDi>935222409500623</basicUdiDi>
    <tradeName>Positive Control Flu/RSV/SARS</tradeName>
    <deviceName>Positive Control Flu/RSV/SARS</deviceName>
    <manufacturerName>SpeeDx Pty. Ltd.</manufacturerName>
    <manufacturerSrn>AU-MF-000016649</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>95006</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:07:17.580Z</lastUpdated>
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  <row>
    <udiDi>08595696305802</udiDi>
    <basicUdiDi>859569630022QB</basicUdiDi>
    <tradeName>myCROBE Universal Control Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MC205/010</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:04:48.439Z</lastUpdated>
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  <row>
    <udiDi>08595696305079</udiDi>
    <basicUdiDi>859569630004Q9</basicUdiDi>
    <tradeName>GeneProof Universal Internal Control</tradeName>
    <deviceName>GeneProof Universal Internal Control</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UNIC/GP/050</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:04:42.833Z</lastUpdated>
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    <udiDi>08436610290142</udiDi>
    <basicUdiDi>843661029VEC00101GM</basicUdiDi>
    <tradeName>VIRCELL® ASPERGILLUS GALACTOMANNAN AG CONTROL</tradeName>
    <deviceName>VIRCELL® ASPERGILLUS GALACTOMANNAN AG CONTROL</deviceName>
    <manufacturerName>Vircell, S.L</manufacturerName>
    <manufacturerSrn>ES-MF-000004099</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080806</emdnCode>
    <emdnDescription>MYCOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VEC001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:57:44.604Z</lastUpdated>
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    <udiDi>08429577004808</udiDi>
    <basicUdiDi>8429577906512DH</basicUdiDi>
    <tradeName>CONTROL POSITIVO EN SECO GDH-TOXINS / DRY GDH-TOXINS POSITIVE CONTROL</tradeName>
    <deviceName>CONTROL POSITIVO EN SECO GDH-TOXINS / DRY POSITIVE CONTROL GDH-TOXINS</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.065.011.12.000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:18:02.428Z</lastUpdated>
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    <udiDi>08429577004051</udiDi>
    <basicUdiDi>8429577923112CW</basicUdiDi>
    <tradeName>CONTROL POSITIVO EN SECO H.PYL-TF  ||  H.PYL-TF DRY POSITIVE CONTROL</tradeName>
    <deviceName>CONTROL POSITIVO EN SECO H.PYL-TF / H.PYL-TF DRY POSITIVE CONTROL</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.231.011.12.000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:17:56.252Z</lastUpdated>
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    <udiDi>08429577003948</udiDi>
    <basicUdiDi>8429577914412D9</basicUdiDi>
    <tradeName>Control positivo en seco Crypto-Giardia-Entamoeba / Crypto-Giardia-Entamoeba Dry Positive Control</tradeName>
    <deviceName>Control positivo en seco Crypto-Giardia-Entamoeba / Crypto-Giardia-Entamoeba Dry Positive Control</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080805</emdnCode>
    <emdnDescription>PARASITOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.144.011.12.000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:17:55.232Z</lastUpdated>
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