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    <tradeName>Homocysteine LS HP</tradeName>
    <deviceName>Homocysteine LS HP</deviceName>
    <manufacturerName>MTD Diagnostics srl</manufacturerName>
    <manufacturerSrn>IT-MF-000053242</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020614</emdnCode>
    <emdnDescription>HOMOCYSTEINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC1420; CC1421</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:33:01.412Z</lastUpdated>
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    <basicUdiDi>B-14560189212777</basicUdiDi>
    <tradeName>14560189212777</tradeName>
    <deviceName>ST AIA-PACK Homocysteine</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020614</emdnCode>
    <emdnDescription>HOMOCYSTEINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0025226</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:02:13.942Z</lastUpdated>
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    <udiDi>D-115H204TSCJW</udiDi>
    <basicUdiDi>B-115H204TSCJW</basicUdiDi>
    <tradeName>Homocysteine (HCY) Assay Kit (Enzymatic Cycling Method)</tradeName>
    <deviceName>Homocysteine (HCY) Assay Kit (Enzymatic Cycling Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020614</emdnCode>
    <emdnDescription>HOMOCYSTEINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>115H204TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:51:47.295Z</lastUpdated>
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    <udiDi>D-115H34TSC3U</udiDi>
    <basicUdiDi>B-115H34TSC3U</basicUdiDi>
    <tradeName>Homocysteine (HCY) Assay Kit (Enzymatic Cycling Method)</tradeName>
    <deviceName>Homocysteine (HCY) Assay Kit (Enzymatic Cycling Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020614</emdnCode>
    <emdnDescription>HOMOCYSTEINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>115H34TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:51:44.887Z</lastUpdated>
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    <udiDi>06975260984589</udiDi>
    <basicUdiDi>B-06975260984589</basicUdiDi>
    <tradeName>06975260984589</tradeName>
    <deviceName>HCY Test Kit (Dry Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Lansion Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001086</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020614</emdnCode>
    <emdnDescription>HOMOCYSTEINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0056-03</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:24:03.719Z</lastUpdated>
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    <udiDi>06974521004172</udiDi>
    <basicUdiDi>B-06974521004172</basicUdiDi>
    <tradeName>HCY Assay kit CLIA</tradeName>
    <deviceName>HCY Assay kit CLIA</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020614</emdnCode>
    <emdnDescription>HOMOCYSTEINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPM074072</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:38:02.316Z</lastUpdated>
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    <udiDi>06974521004165</udiDi>
    <basicUdiDi>B-06974521004165</basicUdiDi>
    <tradeName>HCY Assay kit CLIA</tradeName>
    <deviceName>HCY Assay kit CLIA</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020614</emdnCode>
    <emdnDescription>HOMOCYSTEINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPM074036</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:38:00.721Z</lastUpdated>
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    <udiDi>08426950453024</udiDi>
    <basicUdiDi>842695045302478</basicUdiDi>
    <tradeName>HemosIL Homocysteine</tradeName>
    <deviceName>HemosIL Homocysteine</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020614</emdnCode>
    <emdnDescription>HOMOCYSTEINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020007800</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:04:53.937Z</lastUpdated>
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