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<eudamedExport entity="devices">
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    <basicUdiDi>06152338303J3</basicUdiDi>
    <tradeName>Tissue-Tek Genie® anti-MUC5AC Mouse Monoclonal Antibody [Nd-2]</tradeName>
    <deviceName>Tissue-Tek Genie® anti-MUC5AC Mouse Monoclonal Antibody [Nd-2]</deviceName>
    <manufacturerName>Sakura Finetek USA, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022208</manufacturerSrn>
    <authorisedRepresentativeName>Sakura Finetek Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000007853</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8299-C010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:02:32.276Z</lastUpdated>
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  <row>
    <udiDi>00615233010674</udiDi>
    <basicUdiDi>06152338275JP</basicUdiDi>
    <tradeName>Tissue-Tek Genie®</tradeName>
    <deviceName>Tissue-Tek Genie® anti-Ki67 Mouse Monoclonal Antibody [GM027]</deviceName>
    <manufacturerName>Sakura Finetek USA, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022208</manufacturerSrn>
    <authorisedRepresentativeName>Sakura Finetek Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000007853</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8276-C010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:02:31.496Z</lastUpdated>
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    <udiDi>00615233010605</udiDi>
    <basicUdiDi>06152338296JX</basicUdiDi>
    <tradeName>Tissue-Tek Genie®</tradeName>
    <deviceName>Tissue-Tek Genie® anti-CD10 Rabbit Monoclonal Antibody [QR021]</deviceName>
    <manufacturerName>Sakura Finetek USA, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022208</manufacturerSrn>
    <authorisedRepresentativeName>Sakura Finetek Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000007853</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8386-C010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:02:30.697Z</lastUpdated>
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    <udiDi>00615233010582</udiDi>
    <basicUdiDi>06152338271JF</basicUdiDi>
    <tradeName>Tissue-Tek Genie®</tradeName>
    <deviceName>Tissue-Tek Genie® anti-HER2 Rabbit Monoclonal Antibody [EP3]</deviceName>
    <manufacturerName>Sakura Finetek USA, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022208</manufacturerSrn>
    <authorisedRepresentativeName>Sakura Finetek Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000007853</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8388-M250</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:02:29.898Z</lastUpdated>
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  <row>
    <udiDi>00615233010391</udiDi>
    <basicUdiDi>06152338274JM</basicUdiDi>
    <tradeName>Tissue-Tek Genie®</tradeName>
    <deviceName>Tissue-Tek Genie® anti-CD3 Mouse Monoclonal Antibody [ZM45]</deviceName>
    <manufacturerName>Sakura Finetek USA, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022208</manufacturerSrn>
    <authorisedRepresentativeName>Sakura Finetek Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000007853</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8344-C010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:02:25.867Z</lastUpdated>
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  <row>
    <udiDi>00615233000996</udiDi>
    <basicUdiDi>06152338223J4</basicUdiDi>
    <tradeName>Tissue-Tek Genie®</tradeName>
    <deviceName>Tissue-Tek Genie® anti-CD3 Rabbit Monoclonal Antibody [EP177]</deviceName>
    <manufacturerName>Sakura Finetek USA, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022208</manufacturerSrn>
    <authorisedRepresentativeName>Sakura Finetek Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000007853</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8280-C010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:02:24.278Z</lastUpdated>
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  <row>
    <udiDi>D-GKPD183XU</udiDi>
    <basicUdiDi>B-GKPD183XU</basicUdiDi>
    <tradeName>VEGF Detection Kit (Immunofluorescence Chromatography)</tradeName>
    <deviceName>VEGF Detection Kit (Immunofluorescence Chromatography)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD183</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:39:40.799Z</lastUpdated>
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  <row>
    <udiDi>D-GEFT-T606aHGAF</udiDi>
    <basicUdiDi>B-GEFT-T606aHGAF</basicUdiDi>
    <tradeName>Fecal Occult Blood and Transferrin Combo Rapid Test Device (Feces)</tradeName>
    <deviceName>Fecal Occult Blood and Transferrin Combo Rapid Test Device (Feces)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GEFT-T606a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:35:19.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GEFOB/TF-602aHGZM</udiDi>
    <basicUdiDi>B-GEFOB/TF-602aHGZM</basicUdiDi>
    <tradeName>Fecal Occult Blood and Transferrin Combo Rapid Test Cassette (Feces)</tradeName>
    <deviceName>Fecal Occult Blood and Transferrin Combo Rapid Test Cassette (Feces)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GEFOB/TF-602a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:35:18.813Z</lastUpdated>
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  <row>
    <udiDi>D-1897K</udiDi>
    <basicUdiDi>B-1897K</basicUdiDi>
    <tradeName>D-1897K</tradeName>
    <deviceName>Sialic Acid Assay Kit (Enzymatic Method)</deviceName>
    <manufacturerName>Shanghai Kehua Bio-engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026756</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:16:07.708Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912734321</udiDi>
    <basicUdiDi>692591270279J2</basicUdiDi>
    <tradeName>iFlash-Total β HCG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86327</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:38:12.882Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912734338</udiDi>
    <basicUdiDi>692591270279J2</basicUdiDi>
    <tradeName>iFlash-Total β HCG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86327-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:38:12.870Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-07LE8300R7</udiDi>
    <basicUdiDi>B-07LE8300R7</basicUdiDi>
    <tradeName>2-MET Plasma ELISA Fast Track</tradeName>
    <deviceName>2-MET Plasma ELISA Fast Track</deviceName>
    <manufacturerName>MP Biomedicals Germany GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000020991</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07LE8300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:44:23.450Z</lastUpdated>
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  <row>
    <udiDi>06975977120102</udiDi>
    <basicUdiDi>B-06975977120102</basicUdiDi>
    <tradeName>06975977120102</tradeName>
    <deviceName>EA-IgG, Zta-IgG, and EBNA-IgA Test Kit (Colloidal Gold Immunochromatographic Assay)</deviceName>
    <manufacturerName>Shenzhen Genebiohealth Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046424</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NPC010-100</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:16:59.202Z</lastUpdated>
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  <row>
    <udiDi>06975977120096</udiDi>
    <basicUdiDi>B-06975977120096</basicUdiDi>
    <tradeName>06975977120096</tradeName>
    <deviceName>EA-IgG, Zta-IgG, and EBNA-IgA Test Kit (Colloidal Gold Immunochromatographic Assay)</deviceName>
    <manufacturerName>Shenzhen Genebiohealth Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046424</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NPC010-50</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:16:55.202Z</lastUpdated>
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  <row>
    <udiDi>06975977120089</udiDi>
    <basicUdiDi>B-06975977120089</basicUdiDi>
    <tradeName>06975977120089</tradeName>
    <deviceName>EA-IgG, Zta-IgG, and EBNA-IgA Test Kit (Colloidal Gold Immunochromatographic Assay)</deviceName>
    <manufacturerName>Shenzhen Genebiohealth Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046424</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NPC010-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:16:54.403Z</lastUpdated>
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    <udiDi>06974986814309</udiDi>
    <basicUdiDi>B-06974986814309</basicUdiDi>
    <tradeName>Pro-Gastrin Releasing Peptide (proGRP) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Pro-Gastrin Releasing Peptide (proGRP) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:22:55.503Z</lastUpdated>
  </row>
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    <udiDi>06974986813074</udiDi>
    <basicUdiDi>B-06974986813074</basicUdiDi>
    <tradeName>Pro-Gastrin Releasing Peptide (proGRP) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Pro-Gastrin Releasing Peptide (proGRP) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:19:16.734Z</lastUpdated>
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    <udiDi>06974986813067</udiDi>
    <basicUdiDi>B-06974986813067</basicUdiDi>
    <tradeName>Pro-Gastrin Releasing Peptide (proGRP) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Pro-Gastrin Releasing Peptide (proGRP) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:19:15.918Z</lastUpdated>
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    <udiDi>06974873630340</udiDi>
    <basicUdiDi>B-06974873630340</basicUdiDi>
    <tradeName>06974873630340</tradeName>
    <deviceName>Human Tumor Specific Protein 70 Pleural Effusion Circulating Tumor Cell Kit</deviceName>
    <manufacturerName>Jiangsu Code Biomedical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048158</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KD700302-50</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:01:25.096Z</lastUpdated>
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