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    <tradeName>Albumin urine &amp; CSF control L</tradeName>
    <deviceName>Albumin urine &amp; CSF control L</deviceName>
    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MACOS-005</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:48:49.627Z</lastUpdated>
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    <udiDi>05415168004428</udiDi>
    <basicUdiDi>B-05415168004428</basicUdiDi>
    <tradeName>Albumin urine &amp; CSF control M</tradeName>
    <deviceName>Albumin urine &amp; CSF control M</deviceName>
    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MACON-002</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:48:47.701Z</lastUpdated>
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    <udiDi>05415168004411</udiDi>
    <basicUdiDi>B-05415168004411</basicUdiDi>
    <tradeName>Albumin urine &amp; CSF control H</tradeName>
    <deviceName>Albumin urine &amp; CSF control H</deviceName>
    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MACOX-002</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:48:43.728Z</lastUpdated>
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    <udiDi>05415168004404</udiDi>
    <basicUdiDi>B-05415168004404</basicUdiDi>
    <tradeName>Albumin urine &amp; CSF control L</tradeName>
    <deviceName>Albumin urine &amp; CSF control L</deviceName>
    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MACOS-002</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:48:42.089Z</lastUpdated>
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    <udiDi>05415168003957</udiDi>
    <basicUdiDi>B-05415168003957</basicUdiDi>
    <tradeName>Cystatin C control H</tradeName>
    <deviceName>Cystatin C control H</deviceName>
    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CYCOX-002</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:48:41.286Z</lastUpdated>
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    <udiDi>05415168003940</udiDi>
    <basicUdiDi>B-05415168003940</basicUdiDi>
    <tradeName>Cystatin C control L</tradeName>
    <deviceName>Cystatin C control L</deviceName>
    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CYCOS-002</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:48:23.695Z</lastUpdated>
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    <udiDi>05415168003933</udiDi>
    <basicUdiDi>B-05415168003933</basicUdiDi>
    <tradeName>Cystatin C control M</tradeName>
    <deviceName>Cystatin C control M</deviceName>
    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CYCON-002</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:48:21.295Z</lastUpdated>
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    <udiDi>06947145555382</udiDi>
    <basicUdiDi>694714551085JE</basicUdiDi>
    <tradeName>MAGLUMI Anti-ZnT8 (CLIA) Controls</tradeName>
    <deviceName>Anti-ZnT8 (CLIA)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1602011085MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:42:33.146Z</lastUpdated>
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    <udiDi>00630414246543</udiDi>
    <basicUdiDi>0405686901862W8</basicUdiDi>
    <tradeName>ADVIA Centaur BRAHMS Procalcitonin (PCT) Quality Control</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_PCT Quality Control</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11202698</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:33:36.462Z</lastUpdated>
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    <udiDi>00630414014197</udiDi>
    <basicUdiDi>0405686901864WC</basicUdiDi>
    <tradeName>Atellica IM BRAHMS Procalcitonin Master Curve Material (PCT MCM)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_Procalcitonin Master Curve Material</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10998265</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:32:25.508Z</lastUpdated>
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    <udiDi>00630414953458</udiDi>
    <basicUdiDi>0405686901439VR</basicUdiDi>
    <tradeName>IMMULITE Total IgE Control Module</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_REAG_Total IgE 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10385349</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:25:23.129Z</lastUpdated>
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    <udiDi>00630414953373</udiDi>
    <basicUdiDi>0405686901433VD</basicUdiDi>
    <tradeName>IMMULITE LBP Control Module</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_C_REAG_LBP 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>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10385337</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:25:07.740Z</lastUpdated>
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    <udiDi>00630414953298</udiDi>
    <basicUdiDi>0405686901437VM</basicUdiDi>
    <tradeName>IMMULITE TBG Control Module</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_REAG_TBG 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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10385244</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:25:04.539Z</lastUpdated>
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    <udiDi>00630414953274</udiDi>
    <basicUdiDi>0405686901484VW</basicUdiDi>
    <tradeName>IMMULITE PAPP-A Control Module</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_C_REAG_PAPP-A 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>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10385317</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:25:00.549Z</lastUpdated>
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    <udiDi>00842768013294</udiDi>
    <basicUdiDi>0405686900966WE</basicUdiDi>
    <tradeName>N/T Protein Control PY</tradeName>
    <deviceName>IVDR_27_MAR EB_C_REAG_NT_Prot_Con_PY</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446655</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:20:39.256Z</lastUpdated>
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    <udiDi>00842768007248</udiDi>
    <basicUdiDi>0405686900887WH</basicUdiDi>
    <tradeName>N Lp(a) Control SY</tradeName>
    <deviceName>IVDR_27_MAR EB_B_REAG_N_Lpa_Con_SY</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
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    <emdnCode>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446040</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:19:37.427Z</lastUpdated>
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    <basicUdiDi>0405686900925VY</basicUdiDi>
    <tradeName>Dimension Vista PROT2 CON L</tradeName>
    <deviceName>IVDR_67_MAR EB_C_REAG_V_PROT2_CON</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445936</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:19:05.411Z</lastUpdated>
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    <tradeName>Dimension Vista PROT1 CON L</tradeName>
    <deviceName>IVDR_67_MAR EB_C_REAG_V_PROT1_CON</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445919</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:19:01.408Z</lastUpdated>
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    <tradeName>Apolipoprotein Control Serum CHD</tradeName>
    <deviceName>IVDR_27_MAR EB_C_PROF_REAG_Apo_Con_CHD</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446468</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:07:41.213Z</lastUpdated>
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    <basicUdiDi>0405686900189VJ</basicUdiDi>
    <tradeName>N/T Protein Control SL/L</tradeName>
    <deviceName>IVDR_27_MAR EB_C_PROF_REAG_NT_Prot_Con</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446076</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:06:58.790Z</lastUpdated>
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