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<eudamedExport entity="devices">
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    <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>
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    <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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    <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>
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  <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>
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  <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>
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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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  <row>
    <udiDi>08595696305086</udiDi>
    <basicUdiDi>859569630004Q9</basicUdiDi>
    <tradeName>GeneProof Universal Internal Control</tradeName>
    <deviceName></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/010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:38:13.794Z</lastUpdated>
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  <row>
    <udiDi>08595696305093</udiDi>
    <basicUdiDi>859569630004Q9</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ Universal Internal Control</tradeName>
    <deviceName></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>A58250</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:38:13.166Z</lastUpdated>
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  <row>
    <udiDi>4260465670460</udiDi>
    <basicUdiDi>426046567SRHEPAHH</basicUdiDi>
    <tradeName>Optitrol HEPA-1</tradeName>
    <deviceName>Optitrol HEPA-1</deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</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>SR12025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:41:03.674Z</lastUpdated>
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  <row>
    <udiDi>4260465670422</udiDi>
    <basicUdiDi>426046567SRHEPRJK</basicUdiDi>
    <tradeName>Optitrol HEPR-1</tradeName>
    <deviceName>Optitrol HEPR-1</deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</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>SR12045</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:41:02.050Z</lastUpdated>
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    <udiDi>4260465670378</udiDi>
    <basicUdiDi>426046567SRSeroNegZ5</basicUdiDi>
    <tradeName>Optitrol SeroNeg</tradeName>
    <deviceName>Optitrol SeroNeg</deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</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>SR11000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:40:59.647Z</lastUpdated>
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    <udiDi>4260465670316</udiDi>
    <basicUdiDi>426046567SROrange4T</basicUdiDi>
    <tradeName>Optitrol Orange</tradeName>
    <deviceName>Optitrol Orange</deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</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>SR11061</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:40:58.050Z</lastUpdated>
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    <udiDi>4260465670286</udiDi>
    <basicUdiDi>426046567SRRedKT</basicUdiDi>
    <tradeName>Optitrol Red</tradeName>
    <deviceName>Optitrol Red</deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</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>SR11051</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:40:57.263Z</lastUpdated>
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    <udiDi>4260465670255</udiDi>
    <basicUdiDi>426046567SRGreenA2</basicUdiDi>
    <tradeName>Optitrol Green</tradeName>
    <deviceName>Optitrol Green</deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</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>SR11041</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:40:55.652Z</lastUpdated>
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    <udiDi>4260465670194</udiDi>
    <basicUdiDi>426046567SRYellow8D</basicUdiDi>
    <tradeName>Optitrol Yellow</tradeName>
    <deviceName>Optitrol Yellow</deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</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>SR11021</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:40:53.248Z</lastUpdated>
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    <udiDi>4260465670163</udiDi>
    <basicUdiDi>426046567SRBlueSF</basicUdiDi>
    <tradeName>Optitrol Blue</tradeName>
    <deviceName>Optitrol Blue</deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</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>SR11011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:40:51.649Z</lastUpdated>
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    <udiDi>06970150907495</udiDi>
    <basicUdiDi>697015090000359HY</basicUdiDi>
    <tradeName>ToRCH IgM Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZKB0402</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:46:38.731Z</lastUpdated>
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