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    <tradeName>CALCIUM REAGENT KIT (ARSENAZO III METHOD)</tradeName>
    <deviceName>CALCIUM REAGENT KIT (ARSENAZO III 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>W01010299</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>3021527</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:46:24.180Z</lastUpdated>
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    <udiDi>06925794592392</udiDi>
    <basicUdiDi>B-06925794592392</basicUdiDi>
    <tradeName>CARBON DIOXIDE REAGENT KIT(ENZYMATIC METHOD)</tradeName>
    <deviceName>CARBON DIOXIDE REAGENT KIT(ENZYMATIC 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>W01010299</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>3021712</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:46:20.170Z</lastUpdated>
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    <udiDi>06925794592187</udiDi>
    <basicUdiDi>B-06925794592187</basicUdiDi>
    <tradeName>Ammonia Reagent Kit (Glutamate Dehydrogase Assay)</tradeName>
    <deviceName>Ammonia Reagent Kit (Glutamate Dehydrogase 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>W01010299</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>3021682</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:45:33.413Z</lastUpdated>
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    <udiDi>06925794592170</udiDi>
    <basicUdiDi>B-06925794592170</basicUdiDi>
    <tradeName>Ammonia Reagent Kit (Glutamate Dehydrogase Assay)</tradeName>
    <deviceName>Ammonia Reagent Kit (Glutamate Dehydrogase 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>W01010299</emdnCode>
    <emdnDescription>SUBSTRATES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3021681</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:45:29.410Z</lastUpdated>
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    <udiDi>06925794592118</udiDi>
    <basicUdiDi>B-06925794592118</basicUdiDi>
    <tradeName>β-Hydroxybutyrate Reagent Kit（β-hydroxybutyrate Dehydrogenase Assay）</tradeName>
    <deviceName>β-Hydroxybutyrate Reagent Kit（β-hydroxybutyrate Dehydrogenase 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>W01010299</emdnCode>
    <emdnDescription>SUBSTRATES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3021524</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:45:20.588Z</lastUpdated>
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    <udiDi>06925794592101</udiDi>
    <basicUdiDi>B-06925794592101</basicUdiDi>
    <tradeName>β-Hydroxybutyrate Reagent Kit（β-hydroxybutyrate Dehydrogenase Assay）</tradeName>
    <deviceName>β-Hydroxybutyrate Reagent Kit（β-hydroxybutyrate Dehydrogenase 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>W01010299</emdnCode>
    <emdnDescription>SUBSTRATES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3021600</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:45:19.784Z</lastUpdated>
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    <udiDi>06925794581327</udiDi>
    <basicUdiDi>B-06925794581327</basicUdiDi>
    <tradeName>CALCIUM REAGENT KIT (ARSENAZO III METHOD)</tradeName>
    <deviceName>CALCIUM REAGENT KIT (ARSENAZO III 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>W01010299</emdnCode>
    <emdnDescription>SUBSTRATES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019474</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:44:03.705Z</lastUpdated>
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  <row>
    <udiDi>06925794581310</udiDi>
    <basicUdiDi>B-06925794581310</basicUdiDi>
    <tradeName>CARBON DIOXIDE REAGENT KIT(ENZYMATIC METHOD)</tradeName>
    <deviceName>CARBON DIOXIDE REAGENT KIT(ENZYMATIC 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>W01010299</emdnCode>
    <emdnDescription>SUBSTRATES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019461</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:44:02.918Z</lastUpdated>
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  <row>
    <udiDi>06925794581297</udiDi>
    <basicUdiDi>B-06925794581297</basicUdiDi>
    <tradeName>MAGNESIUM REAGENT KIT（XYLIDYL BLUE METHOD）</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W01010299</emdnCode>
    <emdnDescription>SUBSTRATES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019350</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:42:09.364Z</lastUpdated>
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  <row>
    <udiDi>06925794581143</udiDi>
    <basicUdiDi>B-06925794581143</basicUdiDi>
    <tradeName>INORGANIC PHOSPHORUS REAGENT KIT(DIRECT UV METHOD)</tradeName>
    <deviceName>INORGANIC PHOSPHORUS REAGENT KIT(DIRECT UV 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>W01010299</emdnCode>
    <emdnDescription>SUBSTRATES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019396</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:41:37.440Z</lastUpdated>
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    <udiDi>05907514672264</udiDi>
    <basicUdiDi>B-05907514672264</basicUdiDi>
    <tradeName>ACCENT-200 MYOGLOBIN</tradeName>
    <deviceName>MYOGLOBIN</deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010299</emdnCode>
    <emdnDescription>SUBSTRATES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7-226</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:10:39.101Z</lastUpdated>
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    <udiDi>05907514663019</udiDi>
    <basicUdiDi>B-05907514663019</basicUdiDi>
    <tradeName>CORMAY MYOGLOBIN</tradeName>
    <deviceName>MYOGLOBIN</deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010299</emdnCode>
    <emdnDescription>SUBSTRATES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6-301</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:10:00.791Z</lastUpdated>
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    <udiDi>05907514644810</udiDi>
    <basicUdiDi>B-05907514644810</basicUdiDi>
    <tradeName>PRESTIGE 24i MYOGLOBIN</tradeName>
    <deviceName>MYOGLOBIN</deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010299</emdnCode>
    <emdnDescription>SUBSTRATES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4-481</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:07:17.997Z</lastUpdated>
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    <udiDi>05907514642625</udiDi>
    <basicUdiDi>B-05907514642625</basicUdiDi>
    <tradeName>PRESTIGE 24i MYOGLOBIN</tradeName>
    <deviceName>MYOGLOBIN</deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W01010299</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>4-262</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:04:39.337Z</lastUpdated>
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    <udiDi>09120126380013</udiDi>
    <basicUdiDi>912012638MUXF_HSA01HX</basicUdiDi>
    <tradeName>09120126380013</tradeName>
    <deviceName>Proglycan CCD-Blocker</deviceName>
    <manufacturerName>Proglycan GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000029847</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010299</emdnCode>
    <emdnDescription>SUBSTRATES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PGB-40</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:42:01.171Z</lastUpdated>
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    <basicUdiDi>49874814987481164802UR</basicUdiDi>
    <tradeName>Autokit Total Ketone Bodies R2 Set</tradeName>
    <deviceName>Autokit Total Ketone Bodies R1 Set, Autokit Total Ketone Bodies R2 Set</deviceName>
    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Wako Chemicals Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011552</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010299</emdnCode>
    <emdnDescription>SUBSTRATES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>992-73401</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:32:48.313Z</lastUpdated>
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    <udiDi>04987481164789</udiDi>
    <basicUdiDi>49874814987481164789VS</basicUdiDi>
    <tradeName>Autokit 3-HB R1 Set</tradeName>
    <deviceName>Autokit 3-HB R1 Set, Autokit 3-HB R2 Set</deviceName>
    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Wako Chemicals Europe GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010299</emdnCode>
    <emdnDescription>SUBSTRATES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>998-73501</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:32:44.309Z</lastUpdated>
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    <udiDi>15099590229986</udiDi>
    <basicUdiDi>150995901AccSubstrateHR</basicUdiDi>
    <tradeName>Access Substrate</tradeName>
    <deviceName>Access Substrate</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010299</emdnCode>
    <emdnDescription>SUBSTRATES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81906</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:34:33.301Z</lastUpdated>
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    <basicUdiDi>B-84352873062053</basicUdiDi>
    <tradeName>Clonatest</tradeName>
    <deviceName>Protein (Urine and CSF)</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR10402</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:59:54.071Z</lastUpdated>
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    <tradeName>Clonatest</tradeName>
    <deviceName>Protein (Urine and CSF)</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W01010299</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR10400</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:59:52.459Z</lastUpdated>
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