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    <tradeName>URIC ACID REAGENT KIT（URICASE METHOD）</tradeName>
    <deviceName>URIC ACID REAGENT KIT（URICASE METHOD）</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010232</emdnCode>
    <emdnDescription>URIC ACID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000636</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:30:35.531Z</lastUpdated>
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    <udiDi>06942202259609</udiDi>
    <basicUdiDi>B-06942202259609</basicUdiDi>
    <tradeName>URIC ACID REAGENT KIT（URICASE METHOD）</tradeName>
    <deviceName>URIC ACID REAGENT KIT（URICASE METHOD）</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010232</emdnCode>
    <emdnDescription>URIC ACID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:30:34.325Z</lastUpdated>
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    <udiDi>06942202259593</udiDi>
    <basicUdiDi>B-06942202259593</basicUdiDi>
    <tradeName>UREA REAGENT KIT（ENZYME METHOD）</tradeName>
    <deviceName>UREA REAGENT KIT（ENZYME METHOD）</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:30:33.135Z</lastUpdated>
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    <udiDi>06942202259586</udiDi>
    <basicUdiDi>B-06942202259586</basicUdiDi>
    <tradeName>UREA REAGENT KIT（ENZYME METHOD）</tradeName>
    <deviceName>UREA REAGENT KIT（ENZYME METHOD）</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3016546</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:30:31.931Z</lastUpdated>
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    <udiDi>06942202259579</udiDi>
    <basicUdiDi>B-06942202259579</basicUdiDi>
    <tradeName>UREA REAGENT KIT（ENZYME METHOD）</tradeName>
    <deviceName>UREA REAGENT KIT（ENZYME METHOD）</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012241</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:30:25.923Z</lastUpdated>
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    <udiDi>06942202259562</udiDi>
    <basicUdiDi>B-06942202259562</basicUdiDi>
    <tradeName>UREA REAGENT KIT（ENZYME METHOD）</tradeName>
    <deviceName>UREA REAGENT KIT（ENZYME METHOD）</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000619</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:30:24.724Z</lastUpdated>
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    <udiDi>06942202259555</udiDi>
    <basicUdiDi>B-06942202259555</basicUdiDi>
    <tradeName>UREA REAGENT KIT（ENZYME METHOD）</tradeName>
    <deviceName>UREA REAGENT KIT（ENZYME METHOD）</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3021175</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:30:23.527Z</lastUpdated>
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    <udiDi>06942202259548</udiDi>
    <basicUdiDi>B-06942202259548</basicUdiDi>
    <tradeName>UREA REAGENT KIT（ENZYME METHOD）</tradeName>
    <deviceName>UREA REAGENT KIT（ENZYME METHOD）</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000620</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:30:22.319Z</lastUpdated>
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    <udiDi>06942202259531</udiDi>
    <basicUdiDi>B-06942202259531</basicUdiDi>
    <tradeName>CREATININE REAGENT KIT（ENZYME METHOD）</tradeName>
    <deviceName>CREATININE REAGENT KIT（ENZYME METHOD）</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010207</emdnCode>
    <emdnDescription>CREATININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3016564</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:30:16.312Z</lastUpdated>
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    <udiDi>06942202259524</udiDi>
    <basicUdiDi>B-06942202259524</basicUdiDi>
    <tradeName>CREATININE REAGENT KIT（ENZYME METHOD）</tradeName>
    <deviceName>CREATININE REAGENT KIT（ENZYME METHOD）</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010207</emdnCode>
    <emdnDescription>CREATININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3016513</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:30:15.114Z</lastUpdated>
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    <udiDi>06942202259517</udiDi>
    <basicUdiDi>B-06942202259517</basicUdiDi>
    <tradeName>CREATININE REAGENT KIT（ENZYME METHOD）</tradeName>
    <deviceName>CREATININE REAGENT KIT（ENZYME METHOD）</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010207</emdnCode>
    <emdnDescription>CREATININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3021164</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:30:13.907Z</lastUpdated>
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    <udiDi>06942202259500</udiDi>
    <basicUdiDi>B-06942202259500</basicUdiDi>
    <tradeName>CREATININE REAGENT KIT（ENZYME METHOD）</tradeName>
    <deviceName>CREATININE REAGENT KIT（ENZYME METHOD）</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010207</emdnCode>
    <emdnDescription>CREATININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000653</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:30:12.715Z</lastUpdated>
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    <udiDi>06942202259494</udiDi>
    <basicUdiDi>B-06942202259494</basicUdiDi>
    <tradeName>CREATININE REAGENT KIT（ENZYME METHOD）</tradeName>
    <deviceName>CREATININE REAGENT KIT（ENZYME METHOD）</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010207</emdnCode>
    <emdnDescription>CREATININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000657</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:30:06.713Z</lastUpdated>
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    <udiDi>06942202259487</udiDi>
    <basicUdiDi>B-06942202259487</basicUdiDi>
    <tradeName>CREATININE REAGENT KIT（ENZYME METHOD）</tradeName>
    <deviceName>CREATININE REAGENT KIT（ENZYME METHOD）</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010232</emdnCode>
    <emdnDescription>URIC ACID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000655</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:30:05.507Z</lastUpdated>
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    <udiDi>06942202259470</udiDi>
    <basicUdiDi>B-06942202259470</basicUdiDi>
    <tradeName>CYSTATIN C REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）</tradeName>
    <deviceName>CYSTATIN C REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012490</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:30:04.324Z</lastUpdated>
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    <udiDi>06942202259463</udiDi>
    <basicUdiDi>B-06942202259463</basicUdiDi>
    <tradeName>CYSTATIN C REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）</tradeName>
    <deviceName>CYSTATIN C REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>3021177</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:30:03.106Z</lastUpdated>
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    <udiDi>06942202259456</udiDi>
    <basicUdiDi>B-06942202259456</basicUdiDi>
    <tradeName>β2-MICROGLOBULIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）</tradeName>
    <deviceName>β2-MICROGLOBULIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3021199</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:29:57.113Z</lastUpdated>
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    <udiDi>06942202259449</udiDi>
    <basicUdiDi>B-06942202259449</basicUdiDi>
    <tradeName>α1-MICROGLOBULIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC METHOD）</tradeName>
    <deviceName>α1-MICROGLOBULIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC METHOD）</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012527</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:29:56.139Z</lastUpdated>
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    <udiDi>06942202259432</udiDi>
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    <tradeName>α1-MICROGLOBULIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC METHOD）</tradeName>
    <deviceName>α1-MICROGLOBULIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC METHOD）</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <emdnDescription>A1-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3004649</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:29:54.725Z</lastUpdated>
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    <udiDi>06942202259425</udiDi>
    <basicUdiDi>B-06942202259425</basicUdiDi>
    <tradeName>α1-MICROGLOBULIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC METHOD）</tradeName>
    <deviceName>α1-MICROGLOBULIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC METHOD）</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019004</emdnCode>
    <emdnDescription>A1-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3009786</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:29:53.920Z</lastUpdated>
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