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    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
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    <manufacturerName>PHC Corporation</manufacturerName>
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    <manufacturerName>PHC Corporation</manufacturerName>
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    <tradeName>Atellica IM Homocysteine (HCY)</tradeName>
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    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
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    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
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    <lastUpdated>2026-07-15T21:33:22.824Z</lastUpdated>
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    <tradeName>ADVIA Centaur® CKMB</tradeName>
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    <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>
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    <emdnDescription>CREATINE KINASE - MB MASS (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10309982</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:32:49.941Z</lastUpdated>
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    <tradeName>Dimension EXL N-terminal Pro-Brain Natriuretic Peptide Flex reagent cartridge</tradeName>
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    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
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    <emdnDescription>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-15T21:30:48.817Z</lastUpdated>
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    <tradeName>Dimension Myoglobin Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_MYO</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
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    <tradeName>Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Mass Creatine Kinase MB</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
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    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
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    <emdnDescription>CREATINE KINASE - MB MASS (IC)</emdnDescription>
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    <lastUpdated>2026-07-15T21:29:11.337Z</lastUpdated>
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    <tradeName>Dimension Triglycerides Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_TRIG</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
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    <tradeName>IMMULITE 2000 Troponin I</tradeName>
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    <lastUpdated>2026-07-15T21:25:53.425Z</lastUpdated>
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    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
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    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
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