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    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_HSV2 QC</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
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    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10733034</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T19:52:25.517Z</lastUpdated>
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    <tradeName>Atellica IM Herpes-1 IgG Quality Control (HSV1 QC)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_HSV1 QC</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
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    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
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    <lastUpdated>2026-07-20T19:52:23.918Z</lastUpdated>
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    <tradeName>ADVIA Centaur HAV IgM (aHAVM) Quality Control</tradeName>
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    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
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    <emdnDescription>HEPATITIS VIRUS CONTROLS - INF.IMM.</emdnDescription>
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    <lastUpdated>2026-07-20T19:48:40.332Z</lastUpdated>
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    <basicUdiDi>0405686901475VV</basicUdiDi>
    <tradeName>IMMULITE CMV IgG Control</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_C_REAG_CMV IgG Controls</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10469595</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:41:09.112Z</lastUpdated>
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    <udiDi>00630414481883</udiDi>
    <basicUdiDi>0405686900759W7</basicUdiDi>
    <tradeName>ADVIA Centaur HAV Total (aHAVT) Quality Control</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_aHAVT_QC</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080802</emdnCode>
    <emdnDescription>HEPATITIS VIRUS CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10322682</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:39:37.725Z</lastUpdated>
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    <udiDi>00630414016757</udiDi>
    <basicUdiDi>0405686901855WB</basicUdiDi>
    <tradeName>ADVIA Centaur Herpes-1 IgG (HSV1) Quality Control</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_HSV1 QC</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
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    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:39:11.307Z</lastUpdated>
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    <tradeName>ADVIA Centaur Herpes-2 IgG (HSV2) Quality Control</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_HSV2 QC</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
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    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10720850</reference>
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    <lastUpdated>2026-07-17T19:39:09.705Z</lastUpdated>
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    <tradeName>Aptima CMV Quant Assay Controls Kit</tradeName>
    <deviceName>Aptima CMV Quant Assay</deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-05076</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-17T03:47:46.681Z</lastUpdated>
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    <udiDi>08054320950158</udiDi>
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    <tradeName>08054320950158</tradeName>
    <deviceName>IDS Rubella Avidity Control Set</deviceName>
    <manufacturerName>Technogenetics S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000025331</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-ID5330</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:43:24.484Z</lastUpdated>
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    <tradeName>08054320950134</tradeName>
    <deviceName>IDS CMV Avidity Control Set</deviceName>
    <manufacturerName>Technogenetics S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000025331</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-ID5530</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:43:20.242Z</lastUpdated>
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    <deviceName>IDS CMV Control Set</deviceName>
    <manufacturerName>Technogenetics S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000025331</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-ID5430</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:43:19.031Z</lastUpdated>
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    <tradeName>08054320950110</tradeName>
    <deviceName>IDS Rubella Control Set</deviceName>
    <manufacturerName>Technogenetics S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000025331</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-ID5230</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:43:13.115Z</lastUpdated>
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    <deviceName>IDS TOXO Control Set</deviceName>
    <manufacturerName>Technogenetics S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000025331</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
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    <emdnCode>W0105080805</emdnCode>
    <emdnDescription>PARASITOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-ID5030</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:43:12.785Z</lastUpdated>
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    <tradeName>ADVIA Centaur Rub M quality control material</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_Rubella M Quality Control Material</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
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    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10310286</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:14:08.654Z</lastUpdated>
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    <tradeName>D-697603130CMTBRIFZK0163Z</tradeName>
    <deviceName>GeneStream MTB/RIF Controls</deviceName>
    <manufacturerName>Hangzhou Danwei Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041344</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMTBRIFZK01-AHG4E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:18:17.244Z</lastUpdated>
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    <tradeName>D-697603130CMTBMDRZK01639</tradeName>
    <deviceName>GeneStream MTB MDR Controls</deviceName>
    <manufacturerName>Hangzhou Danwei Biotechnology Co., Ltd</manufacturerName>
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    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMTBMDRZK01-AHG4E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:18:11.593Z</lastUpdated>
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    <deviceName>GeneStream GBS Controls</deviceName>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:18:06.582Z</lastUpdated>
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    <deviceName>GeneStream Dengue Virus Typing1,2,3,4 Controls</deviceName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDGVZK01-AHG4E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:18:00.582Z</lastUpdated>
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    <tradeName>D-69509960AMTBZK01DJEZ</tradeName>
    <deviceName>MTBC Controls</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMTBZK01-AHG2E</reference>
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    <lastUpdated>2026-07-17T00:52:57.320Z</lastUpdated>
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    <tradeName>LIAISON® Control Mycoplasma pneumoniae IgG</tradeName>
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    <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>317021</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:31:59.910Z</lastUpdated>
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