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    <basicUdiDi>69471455642WM</basicUdiDi>
    <tradeName>Biossays Serum Amyloid A (Latex Immunoturbidimetric)</tradeName>
    <deviceName>Serum Amyloid A (Latex Immunoturbidimetric)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130513001S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:43:05.235Z</lastUpdated>
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  <row>
    <udiDi>05204309137084</udiDi>
    <basicUdiDi>5204309000018NV</basicUdiDi>
    <tradeName>CRP</tradeName>
    <deviceName>CRP</deviceName>
    <manufacturerName>Medicon Hellas SA</manufacturerName>
    <manufacturerSrn>GR-MF-000013625</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1417-0527</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:51:50.680Z</lastUpdated>
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    <udiDi>04987595301711</udiDi>
    <basicUdiDi>4987595PF1071KXQ</basicUdiDi>
    <tradeName>PATHFAST hsCRP</tradeName>
    <deviceName>PATHFAST hsCRP</deviceName>
    <manufacturerName>PHC Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000008516</manufacturerSrn>
    <authorisedRepresentativeName>PHC Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002692</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30171</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:40:57.451Z</lastUpdated>
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    <udiDi>00630414610887</udiDi>
    <basicUdiDi>0405686902328VN</basicUdiDi>
    <tradeName>Atellica CH Revised C‑Reactive Protein (RCRP)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_RCRP</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11537223</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:36:16.732Z</lastUpdated>
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    <udiDi>00630414610856</udiDi>
    <basicUdiDi>0405686902306VC</basicUdiDi>
    <tradeName>Atellica CH Anti-Streptolysin-O_3 (ASO_3)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_ASO_3</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11537212</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:36:15.925Z</lastUpdated>
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  <row>
    <udiDi>00842768016028</udiDi>
    <basicUdiDi>0405686901077VD</basicUdiDi>
    <tradeName>Dimension CardioPhase high sensitivity CRP Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_CCRP</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10444897</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:29:47.949Z</lastUpdated>
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    <udiDi>00630414982151</udiDi>
    <basicUdiDi>0405686901368VT</basicUdiDi>
    <tradeName>IMMULITE 2000 Anti-CCP IgG</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_REAG_KIT_Anti-CCP IgG</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10368607</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:27:31.216Z</lastUpdated>
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    <udiDi>00842768013317</udiDi>
    <basicUdiDi>0405686900957WD</basicUdiDi>
    <tradeName>N Latex ADNase B</tradeName>
    <deviceName>IVDR_27_MAR EB_B_KIT_N_La_ADN_B</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021101</emdnCode>
    <emdnDescription>ANTI-STREPTOCOCCAL DEOXYRIBONUCLEASE B (ANTI-DNAASE B)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446658</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:20:40.836Z</lastUpdated>
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  <row>
    <udiDi>00842768007880</udiDi>
    <basicUdiDi>0405686900962W6</basicUdiDi>
    <tradeName>N Latex SAA</tradeName>
    <deviceName>IVDR_27_MAR EB_B_KIT_N_La_SAA</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446108</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:19:42.335Z</lastUpdated>
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  <row>
    <udiDi>00842768006883</udiDi>
    <basicUdiDi>0405686900886WF</basicUdiDi>
    <tradeName>N Latex RF Kit</tradeName>
    <deviceName>IVDR_27_MAR EB_B_KIT_N_La_RF</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445991</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:19:14.319Z</lastUpdated>
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  <row>
    <udiDi>00842768006791</udiDi>
    <basicUdiDi>0405686900878WG</basicUdiDi>
    <tradeName>N Latex ASL</tradeName>
    <deviceName>IVDR_27_MAR EB_B_REAG_N_La_ASL</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445983</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:19:12.474Z</lastUpdated>
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  <row>
    <udiDi>00842768006234</udiDi>
    <basicUdiDi>0405686900928W6</basicUdiDi>
    <tradeName>Dimension Vista Rheumatoid Factors Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_MAR EB_B_KIT_V_RF</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445908</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:18:59.004Z</lastUpdated>
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  <row>
    <udiDi>00842768006081</udiDi>
    <basicUdiDi>0405686900912VP</basicUdiDi>
    <tradeName>Dimension Vista C-Reactive Protein Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_MAR EB_C_KIT_V_CRP</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445893</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:18:43.860Z</lastUpdated>
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    <udiDi>D-hs-CRP706-AEUC</udiDi>
    <basicUdiDi>B-hs-CRP706-AEUC</basicUdiDi>
    <tradeName>hs-CRP High-sensitivity C-reactive Protein (CLIA)</tradeName>
    <deviceName>hs-CRP High-sensitivity C-reactive Protein (CLIA)</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>hs-CRP706-AE10Y, hs-CRP706-AE10N, hs-CRP706-AE20Y, hs-CRP706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:19:25.272Z</lastUpdated>
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  <row>
    <udiDi>D-VID119F2</udiDi>
    <basicUdiDi>B-VID119F2</basicUdiDi>
    <tradeName>Anti-cyclic Citrullinated Peptide Antibody Test Kit (FIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID119-01-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:20:15.369Z</lastUpdated>
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    <udiDi>D-TD-HNKX-CED-704A</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-704A</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-704A</tradeName>
    <deviceName>Anti-cyclic Citrullinated Peptide Antibody Kit (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>Hunan Kangxin Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020121</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:57:49.101Z</lastUpdated>
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    <udiDi>D-TD-HNKX-CED-694R</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-694R</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-694R</tradeName>
    <deviceName>Rheumatoid Factor Kit (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>Hunan Kangxin Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020121</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:57:48.310Z</lastUpdated>
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    <udiDi>D-TD-HNKX-CED-213V</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-213V</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-213V</tradeName>
    <deviceName>PCT &amp; IL-6 Kit (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>Hunan Kangxin Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020121</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>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:56:00.935Z</lastUpdated>
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    <udiDi>D-TD-HNKX-CED-203T</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-203T</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-203T</tradeName>
    <deviceName>CRP &amp; Serum Amyloid A Kit (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>Hunan Kangxin Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020121</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>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:56:00.418Z</lastUpdated>
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    <udiDi>D-TD-HNKX-CED-1746</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-1746</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-1746</tradeName>
    <deviceName>C-Reactive Protein Kit (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>Hunan Kangxin Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020121</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:55:53.735Z</lastUpdated>
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