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    <tradeName>06974760129933</tradeName>
    <deviceName>Lipoprotein-associated Phospholipase A2 （Lp-PLA2）Assay Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Shenzhen AmTech Bioengineering Ltd., Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000043067</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021312</emdnCode>
    <emdnDescription>LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1: 2×60 mL, R2: 2×15 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:41:17.467Z</lastUpdated>
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    <udiDi>06974760129629</udiDi>
    <basicUdiDi>B-06974760129629</basicUdiDi>
    <tradeName>06974760129629</tradeName>
    <deviceName>Lipoprotein-associated Phospholipase A2（Lp-PLA2） Assay Kit（Enzymatic Method）</deviceName>
    <manufacturerName>Shenzhen AmTech Bioengineering Ltd., Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000043067</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021312</emdnCode>
    <emdnDescription>LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1: 2×60 mL, R2: 2×15 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:40:12.202Z</lastUpdated>
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    <udiDi>06974674892695</udiDi>
    <basicUdiDi>B-06974674892695</basicUdiDi>
    <tradeName>Lipoprotein-associated phospholipaseA2(Lp-PLA2) Detection Kit(CLIA)</tradeName>
    <deviceName>Lipoprotein-associated phospholipaseA2(Lp-PLA2) Detection Kit(CLIA)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021312</emdnCode>
    <emdnDescription>LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0141</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:16:52.642Z</lastUpdated>
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    <udiDi>06974521004257</udiDi>
    <basicUdiDi>B-06974521004257</basicUdiDi>
    <tradeName>Lp-PLA2 Assay kit CLIA</tradeName>
    <deviceName>Lp-PLA2 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>W01021312</emdnCode>
    <emdnDescription>LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPM072072</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:38:15.136Z</lastUpdated>
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    <udiDi>06974521004240</udiDi>
    <basicUdiDi>B-06974521004240</basicUdiDi>
    <tradeName>Lp-PLA2 Assay kit CLIA</tradeName>
    <deviceName>Lp-PLA2 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>W01021312</emdnCode>
    <emdnDescription>LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPM072036</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:38:13.529Z</lastUpdated>
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    <udiDi>06974323018490</udiDi>
    <basicUdiDi>B-06974323018490</basicUdiDi>
    <tradeName>06974323018490</tradeName>
    <deviceName>Lp-PLA2 rapid test cassette (Rare earth nano fluorescence immunochromatography)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021312</emdnCode>
    <emdnDescription>LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IF030</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:02:17.097Z</lastUpdated>
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    <udiDi>06974323018483</udiDi>
    <basicUdiDi>B-06974323018483</basicUdiDi>
    <tradeName>06974323018483</tradeName>
    <deviceName>Lp-PLA2 rapid test cassette (Rare earth nano fluorescence immunochromatography)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021312</emdnCode>
    <emdnDescription>LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IF030</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:02:14.694Z</lastUpdated>
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    <udiDi>06974323018476</udiDi>
    <basicUdiDi>B-06974323018476</basicUdiDi>
    <tradeName>06974323018476</tradeName>
    <deviceName>Lp-PLA2 rapid test cassette (Rare earth nano fluorescence immunochromatography)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021312</emdnCode>
    <emdnDescription>LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IF030</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:02:13.097Z</lastUpdated>
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    <udiDi>06973841000994</udiDi>
    <basicUdiDi>B-06973841000994</basicUdiDi>
    <tradeName>Lp-PLA2 Test Kit (FIA)</tradeName>
    <deviceName>Lp-PLA2 Test Kit (FIA)</deviceName>
    <manufacturerName>Guangdong Wesail Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008828</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021312</emdnCode>
    <emdnDescription>LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BA0280</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:39:09.644Z</lastUpdated>
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    <udiDi>06973720138060</udiDi>
    <basicUdiDi>B-06973720138060</basicUdiDi>
    <tradeName>06973720138060</tradeName>
    <deviceName>Lipoprotein-Related Phospholipase A2 (Lp-PLA2) Test Kit (Immunofluorescence Method)</deviceName>
    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019908</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021312</emdnCode>
    <emdnDescription>LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF-Lp-PLA2-20</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:33:03.523Z</lastUpdated>
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    <udiDi>06973720131795</udiDi>
    <basicUdiDi>B-06973720131795</basicUdiDi>
    <tradeName>06973720131795</tradeName>
    <deviceName>Lipoprotein-Related Phospholipase A2 (Lp-PLA2) Test Kit (Immunofluorescence Method)</deviceName>
    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019908</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021312</emdnCode>
    <emdnDescription>LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF-Lp-PLA2-40</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:32:21.047Z</lastUpdated>
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    <udiDi>06972719604739</udiDi>
    <basicUdiDi>B-06972719604739</basicUdiDi>
    <tradeName>06972719604739</tradeName>
    <deviceName>Lipoprotein-associated Phospholipase A2 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021312</emdnCode>
    <emdnDescription>LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:47:25.404Z</lastUpdated>
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    <udiDi>06972719604722</udiDi>
    <basicUdiDi>B-06972719604722</basicUdiDi>
    <tradeName>06972719604722</tradeName>
    <deviceName>Lipoprotein-associated Phospholipase A2 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021312</emdnCode>
    <emdnDescription>LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:47:22.194Z</lastUpdated>
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    <udiDi>06972719601660</udiDi>
    <basicUdiDi>B-06972719601660</basicUdiDi>
    <tradeName>06972719601660</tradeName>
    <deviceName>Lipoprotein-associated Phospholipase A2 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021312</emdnCode>
    <emdnDescription>LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:37:01.356Z</lastUpdated>
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    <udiDi>06972719601653</udiDi>
    <basicUdiDi>B-06972719601653</basicUdiDi>
    <tradeName>06972719601653</tradeName>
    <deviceName>Lipoprotein-associated Phospholipase A2 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021312</emdnCode>
    <emdnDescription>LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:36:59.891Z</lastUpdated>
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    <udiDi>06972719601639</udiDi>
    <basicUdiDi>B-06972719601639</basicUdiDi>
    <tradeName>06972719601639</tradeName>
    <deviceName>Lipoprotein-associated Phospholipase A2 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021312</emdnCode>
    <emdnDescription>LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:36:56.549Z</lastUpdated>
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    <udiDi>06972719600908</udiDi>
    <basicUdiDi>B-06972719600908</basicUdiDi>
    <tradeName>06972719600908</tradeName>
    <deviceName>Lipoprotein-associated Phospholipase A2 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021312</emdnCode>
    <emdnDescription>LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HN215370005</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:33:32.004Z</lastUpdated>
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    <udiDi>06971354100439</udiDi>
    <basicUdiDi>B-06971354100439</basicUdiDi>
    <tradeName>ReLIA</tradeName>
    <deviceName>Lipoprotein-associated  phospholipase A2 test (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>ReLIA Biotechnologies (Jiangsu), Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000042042</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021312</emdnCode>
    <emdnDescription>LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RF16227-50T</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:52:23.377Z</lastUpdated>
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    <udiDi>06971354100422</udiDi>
    <basicUdiDi>B-06971354100422</basicUdiDi>
    <tradeName>ReLIA</tradeName>
    <deviceName>Lipoprotein-associated  phospholipase A2 test (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>ReLIA Biotechnologies (Jiangsu), Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000042042</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021312</emdnCode>
    <emdnDescription>LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RF16101-20T</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:52:22.026Z</lastUpdated>
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    <udiDi>D-02B0025YR</udiDi>
    <basicUdiDi>B-02B0025YR</basicUdiDi>
    <tradeName>D-02B0025YR</tradeName>
    <deviceName>Lipoprotein-associated Phospholipase A2 Reagent Kit</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021312</emdnCode>
    <emdnDescription>LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2L001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:29:19.832Z</lastUpdated>
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