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    <deviceName>B·R·A·H·M·S AFP KRYPTOR DILUENT</deviceName>
    <manufacturerName>B·R·A·H·M·S GmbH</manufacturerName>
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    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
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    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
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    <tradeName>IMMULITE 2000 TBG Sample Diluent</tradeName>
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    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:42:20.281Z</lastUpdated>
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    <tradeName>IMMULITE Ascorbic Acid</tradeName>
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    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
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    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T06:10:58.467Z</lastUpdated>
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    <tradeName>IMMULITE 2000 Vitamin B12/Folic Acid Sample Diluent</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_A_REAG_Vitamin B12/Folic Acid Sample Dil</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <tradeName>IMMULITE 2000 Third Generation TSH Sample Diluent</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_A_REAG_Third Generation TSH Sample Diluent</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T06:09:26.902Z</lastUpdated>
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    <tradeName>IMMULITE 2000 Intact PTH Sample Diluent</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_A_REAG_Intact PTH Sample Diluent</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>10387060</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T06:09:26.114Z</lastUpdated>
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    <tradeName>IMMULITE 2000 Insulin Sample Diluent</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_A_REAG_Insulin Sample Diluent</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010114</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IG'S)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10387066</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T06:09:25.301Z</lastUpdated>
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    <udiDi>00630414953953</udiDi>
    <basicUdiDi>0405686901336VE</basicUdiDi>
    <tradeName>IMMULITE 2000 IgG/IgM Sample Diluent</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_A_REAG_IgG/IgM Sample Diluent</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010114</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IG'S)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10387663</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T06:09:24.550Z</lastUpdated>
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    <tradeName>IMMULITE 2000 IGF-I Sample Diluent</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_A_REAG_IGF-I Sample Diluent</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010114</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IG'S)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10387074</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T06:09:20.496Z</lastUpdated>
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    <basicUdiDi>0405686901315V6</basicUdiDi>
    <tradeName>IMMULITE 2000 Homocysteine Sample Diluent</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_A_KIT_Homocysteine Sample Diluent</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010114</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IG'S)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10387055</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T06:09:19.719Z</lastUpdated>
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    <tradeName>IMMULITE 2000 HCG Sample Diluent</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_A_REAG_HCG Sample Diluent</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010114</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IG'S)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10387051</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T06:09:18.912Z</lastUpdated>
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    <tradeName>IMMULITE 2000 High Sensitivity CRP Sample Diluent</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_A_REAG_High Sensitivity CRP Smple Dil</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IG'S)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10387052</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T06:09:12.491Z</lastUpdated>
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    <tradeName>IMMULITE 2000 C-Peptide Sample Diluent</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_A_REAG_C-Peptide Sample Diluent</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010114</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IG'S)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10387068</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T06:09:11.696Z</lastUpdated>
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    <tradeName>Emit 2000 Siro/Tacro Sample Pretreatment Reagent</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Siro.Tacro Sample Pretreatment Reag</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010114</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IG'S)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10488260</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:30:49.617Z</lastUpdated>
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    <tradeName>IMMULITE 2000 Multi-Diluent 2</tradeName>
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    <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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010114</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IG'S)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10387058</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:26:57.643Z</lastUpdated>
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    <basicUdiDi>0405686901355VJ</basicUdiDi>
    <tradeName>IMMULITE 2000 Thyroglobulin Sample Diluent</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_A_REAG_Thyroglobulin Sample Diluent</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010114</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IG'S)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10387073</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:25:32.523Z</lastUpdated>
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    <tradeName>IMMULITE 2000 NT-ProBNP Sample Diluent</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_A_REAG_NT-ProBNP Sample Diluent</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010114</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IG'S)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10387059</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:25:30.312Z</lastUpdated>
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    <deviceName>IVDR_67_LLB_DUB-C_A_REAG_Multi-Diluent 1</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010114</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IG'S)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10387057</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:25:28.627Z</lastUpdated>
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