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    <tradeName>Heparin Binding Protein Kit（CLIA）</tradeName>
    <deviceName>Heparin Binding Protein Kit（CLIA）</deviceName>
    <manufacturerName>Jiangxi Medicalsystem Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050651</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA1478B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:58:19.305Z</lastUpdated>
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    <udiDi>06978945081542</udiDi>
    <basicUdiDi>B-06978945081542</basicUdiDi>
    <tradeName>Heparin Binding Protein Kit（CLIA）</tradeName>
    <deviceName>Heparin Binding Protein Kit（CLIA）</deviceName>
    <manufacturerName>Jiangxi Medicalsystem Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050651</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA1478A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:58:17.698Z</lastUpdated>
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    <udiDi>06978896415908</udiDi>
    <basicUdiDi>B-06978896415908</basicUdiDi>
    <tradeName>06978896415908</tradeName>
    <deviceName>Serum Amyloid A (SAA) 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>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF2-SAA-40</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:49:27.817Z</lastUpdated>
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    <udiDi>06978198482134</udiDi>
    <basicUdiDi>B-06978198482134</basicUdiDi>
    <tradeName>C-Reactive Protein/Serum Amyloid A (CRP/SAA) Test Kit (Immunofluorescence)</tradeName>
    <deviceName>C-Reactive Protein/Serum Amyloid A (CRP/SAA) Test Kit (Immunofluorescence)</deviceName>
    <manufacturerName>Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046524</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2213</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:42:30.923Z</lastUpdated>
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    <udiDi>06977698403168</udiDi>
    <basicUdiDi>B-06977698403168</basicUdiDi>
    <tradeName>Serum Amyloid Protein A (SAA) Quantitative Test Cassette (Quantum Dot Fluorescence Immunochromatography)</tradeName>
    <deviceName>Serum Amyloid Protein A (SAA) Quantitative Test Cassette (Quantum Dot Fluorescence Immunochromatography)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD061</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:29:12.433Z</lastUpdated>
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    <udiDi>06977565583047</udiDi>
    <basicUdiDi>B-06977565583047</basicUdiDi>
    <tradeName>IL-6 Rapid Quantitative Test</tradeName>
    <deviceName>IL-6 Rapid Quantitative Test</deviceName>
    <manufacturerName>Coei Biotech Co.Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049509</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3042</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:22:09.281Z</lastUpdated>
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    <udiDi>06977565581944</udiDi>
    <basicUdiDi>B-06977565581944</basicUdiDi>
    <tradeName>SAA (Serum Amyloid A Protein) Rapid Quantitative Test</tradeName>
    <deviceName>SAA (Serum Amyloid A Protein) Rapid Quantitative Test</deviceName>
    <manufacturerName>Coei Biotech Co.Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049509</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1942</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:21:54.067Z</lastUpdated>
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    <udiDi>06977565581845</udiDi>
    <basicUdiDi>B-06977565581845</basicUdiDi>
    <tradeName>PCT (Procalcitonin) Rapid Quantitative Test</tradeName>
    <deviceName>PCT (Procalcitonin) Rapid Quantitative Test</deviceName>
    <manufacturerName>Coei Biotech Co.Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049509</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1842</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:21:35.607Z</lastUpdated>
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    <udiDi>06975679490855</udiDi>
    <basicUdiDi>B-06975679490855</basicUdiDi>
    <tradeName>SAA (Serum amyloid A) Rapid Quantitative Test</tradeName>
    <deviceName>SAA (Serum amyloid A) Rapid Quantitative Test</deviceName>
    <manufacturerName>Hunan Ehome Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045177</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAA</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:42:02.086Z</lastUpdated>
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    <udiDi>06975424226791</udiDi>
    <basicUdiDi>B-06975424226791</basicUdiDi>
    <tradeName>Anti-MCV CLIA Assay Kit</tradeName>
    <deviceName>Anti-MCV CLIA Assay Kit</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL20462EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:47:17.222Z</lastUpdated>
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    <udiDi>06975424226715</udiDi>
    <basicUdiDi>B-06975424226715</basicUdiDi>
    <tradeName>Rheumatoid Factor IgA CLIA Assay Kit</tradeName>
    <deviceName>Rheumatoid Factor IgA CLIA Assay Kit</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL20572EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:47:03.636Z</lastUpdated>
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    <udiDi>06975424226708</udiDi>
    <basicUdiDi>B-06975424226708</basicUdiDi>
    <tradeName>Rheumatoid Factor IgG CLIA Assay Kit</tradeName>
    <deviceName>Rheumatoid Factor IgG CLIA Assay Kit</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL20202EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:47:02.832Z</lastUpdated>
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    <udiDi>06975424225855</udiDi>
    <basicUdiDi>B-06975424225855</basicUdiDi>
    <tradeName>Anti-MCV Assay Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>Anti-MCV Assay Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL247301C</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:44:09.419Z</lastUpdated>
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    <udiDi>06975424225084</udiDi>
    <basicUdiDi>B-06975424225084</basicUdiDi>
    <tradeName>06975424225084</tradeName>
    <deviceName>Anti-MCV Assay Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL247302</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:42:21.243Z</lastUpdated>
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    <udiDi>06975424224261</udiDi>
    <basicUdiDi>B-06975424224261</basicUdiDi>
    <tradeName>Anti-MCV CLIA Assay Kit</tradeName>
    <deviceName>Anti-MCV CLIA Assay Kit</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL30462EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:41:36.613Z</lastUpdated>
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    <udiDi>06975424224186</udiDi>
    <basicUdiDi>B-06975424224186</basicUdiDi>
    <tradeName>Rheumatoid Factor IgA CLIA Assay Kit</tradeName>
    <deviceName>Rheumatoid Factor IgA CLIA Assay Kit</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL30572EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:41:23.489Z</lastUpdated>
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    <udiDi>06975424224179</udiDi>
    <basicUdiDi>B-06975424224179</basicUdiDi>
    <tradeName>Rheumatoid Factor IgG CLIA Assay Kit</tradeName>
    <deviceName>Rheumatoid Factor IgG CLIA Assay Kit</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL30202EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:41:22.692Z</lastUpdated>
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    <udiDi>06975424223288</udiDi>
    <basicUdiDi>B-06975424223288</basicUdiDi>
    <tradeName>Anti-MCV Assay Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>Anti-MCV Assay Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 tests/ kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:38:54.428Z</lastUpdated>
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    <udiDi>06975424222397</udiDi>
    <basicUdiDi>B-06975424222397</basicUdiDi>
    <tradeName>Anti-MCV CLIA Assay Kit</tradeName>
    <deviceName>Anti-MCV CLIA Assay Kit</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:38:16.761Z</lastUpdated>
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    <udiDi>06975424222380</udiDi>
    <basicUdiDi>B-06975424222380</basicUdiDi>
    <tradeName>Rheumatoid Factor IgA CLIA Assay Kit</tradeName>
    <deviceName>Rheumatoid Factor IgA CLIA Assay Kit</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:38:15.958Z</lastUpdated>
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