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    <tradeName>Optitrol Paediatric G Pos</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR15015</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T03:46:36.612Z</lastUpdated>
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    <udiDi>00850075956432</udiDi>
    <basicUdiDi>0816784020127Y2</basicUdiDi>
    <tradeName>Optitrol Paediatric M Neg</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
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    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>Optitrol Lyme/TBE G</tradeName>
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    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
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    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
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    <lastUpdated>2026-07-24T03:46:35.174Z</lastUpdated>
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    <basicUdiDi>0816784020126XY</basicUdiDi>
    <tradeName>Optitrol Lyme/TBE G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
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    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR17017</reference>
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    <lastUpdated>2026-07-24T03:46:34.994Z</lastUpdated>
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    <udiDi>00850075957170</udiDi>
    <basicUdiDi>0816784020132XT</basicUdiDi>
    <tradeName>Optitrol Lyme/TBE M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR17028</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T03:46:34.664Z</lastUpdated>
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    <basicUdiDi>0816784020132XT</basicUdiDi>
    <tradeName>Optitrol Lyme/TBE M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
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    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR17027</reference>
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    <lastUpdated>2026-07-24T03:46:34.597Z</lastUpdated>
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    <basicUdiDi>0816784020120XL</basicUdiDi>
    <tradeName>Optitrol Syphilis G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
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    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR11137</reference>
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    <lastUpdated>2026-07-24T03:46:34.308Z</lastUpdated>
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    <udiDi>00850075956630</udiDi>
    <basicUdiDi>0816784020130XP</basicUdiDi>
    <tradeName>Optitrol ToRCH M Pos</tradeName>
    <deviceName>Optitrol ToRCH M Pos</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
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    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR13027</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:23.563Z</lastUpdated>
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    <basicUdiDi>0816784020128Y4</basicUdiDi>
    <tradeName>Optitrol ToRCH G Neg</tradeName>
    <deviceName>Optitrol ToRCH G Pos</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080899</emdnCode>
    <emdnDescription>CONTROLS - INF. IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR13049</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:22.766Z</lastUpdated>
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    <udiDi>00630414976686</udiDi>
    <basicUdiDi>0405686900734VP</basicUdiDi>
    <tradeName>IMMULITE Syphilis Control Module</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_C_REAG_Syphilis Control Module</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10469593</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:42:27.484Z</lastUpdated>
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    <udiDi>00850075956623</udiDi>
    <basicUdiDi>0816784020128Y4</basicUdiDi>
    <tradeName>Optitrol ToRCH G Pos</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080899</emdnCode>
    <emdnDescription>CONTROLS - INF. IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR13019</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:36:38.592Z</lastUpdated>
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    <udiDi>00850075956609</udiDi>
    <basicUdiDi>0816784020128Y4</basicUdiDi>
    <tradeName>Optitrol ToRCH G Pos</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080899</emdnCode>
    <emdnDescription>CONTROLS - INF. IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR13017</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:36:38.404Z</lastUpdated>
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    <basicUdiDi>0816784020128Y4</basicUdiDi>
    <tradeName>Optitrol ToRCH G Neg</tradeName>
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    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
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    <emdnDescription>CONTROLS - INF. IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR13047</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:36:33.324Z</lastUpdated>
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    <tradeName>Optitrol ToRCH M Pos</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
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    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR13029</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:36:08.433Z</lastUpdated>
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    <basicUdiDi>0816784020130XP</basicUdiDi>
    <tradeName>Optitrol ToRCH M Neg</tradeName>
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    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
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    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR13057</reference>
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    <lastUpdated>2026-07-23T19:36:04.407Z</lastUpdated>
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    <udiDi>08056771104210</udiDi>
    <basicUdiDi>805677131160145</basicUdiDi>
    <tradeName>LIAISON® Control Legionella Urinary Ag</tradeName>
    <deviceName>LIAISON® Control Legionella Urinary Ag</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>311601</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-22T22:39:56.252Z</lastUpdated>
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    <tradeName>LIAISON® Biotrin Control Parvovirus B19 IgM Plus</tradeName>
    <deviceName>LIAISON® Biotrin Control Parvovirus B19 IgM Plus</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-22T22:39:49.820Z</lastUpdated>
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    <tradeName>LIAISON® Biotrin Control Parvovirus B19 IgG Plus</tradeName>
    <deviceName>LIAISON® Biotrin Control Parvovirus B19 IgG Plus</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>LIAISON® MUREX Control Anti-HEV IgG</tradeName>
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    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
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    <emdnCode>W0105080802</emdnCode>
    <emdnDescription>HEPATITIS VIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>311271</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-22T22:39:43.405Z</lastUpdated>
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    <tradeName>LIAISON® Control QuantiFERON®-TB Gold Plus</tradeName>
    <deviceName>LIAISON® Control QuantiFERON®-TB Gold Plus</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>311011</reference>
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    <lastUpdated>2026-07-22T22:39:37.007Z</lastUpdated>
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