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    <tradeName>6-Acetylmorphine Enzyme Immunoassay</tradeName>
    <deviceName>6-Acetylmorphine Enzyme Immunoassay</deviceName>
    <manufacturerName>Lin-Zhi International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003373</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090116</emdnCode>
    <emdnDescription>6-ACETHYLMORPHIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08240035190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:33:08.294Z</lastUpdated>
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    <tradeName>Emit II Plus 6-Acetylmorphine Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_6-Acetylmorphine Assay</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090116</emdnCode>
    <emdnDescription>6-ACETHYLMORPHIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10730975</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:23:21.700Z</lastUpdated>
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    <tradeName>Emit II Plus 6-Acetylmorphine Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
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    <emdnDescription>6-ACETHYLMORPHIUM</emdnDescription>
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    <lastUpdated>2026-07-10T03:46:10.306Z</lastUpdated>
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    <tradeName>Emit II Plus 6-Acetylmorphine Assay</tradeName>
    <deviceName></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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090116</emdnCode>
    <emdnDescription>6-ACETHYLMORPHIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10481483</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:45:00.941Z</lastUpdated>
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    <udiDi>06952804803506</udiDi>
    <basicUdiDi>B-06952804803506</basicUdiDi>
    <tradeName>6-Acetylmorphine FIA</tradeName>
    <deviceName>6-Acetylmorphine FIA</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090116</emdnCode>
    <emdnDescription>6-ACETHYLMORPHIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACE-H23F3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:25:08.227Z</lastUpdated>
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