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    <deviceName>Cardiac Troponin I/Creatine Kinase MB/Myoglobin 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>W01021399</emdnCode>
    <emdnDescription>CARDIAC MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL191206</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:39:57.741Z</lastUpdated>
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    <udiDi>06975424221420</udiDi>
    <basicUdiDi>B-06975424221420</basicUdiDi>
    <tradeName>D-Dimer Assay Kit（Fluorescence Immunoassay）</tradeName>
    <deviceName>D-Dimer 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>W01021399</emdnCode>
    <emdnDescription>CARDIAC MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 tests/ kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:36:39.140Z</lastUpdated>
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    <udiDi>06975424221291</udiDi>
    <basicUdiDi>B-06975424221291</basicUdiDi>
    <tradeName>Cardiac Troponin I/Creatine Kinase MB/Myoglobin Assay Kit(Fluorescence Immunoassay)</tradeName>
    <deviceName>Cardiac Troponin I/Creatine Kinase MB/Myoglobin 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>
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    <emdnDescription>CARDIAC MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 tests/ kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:36:27.102Z</lastUpdated>
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    <udiDi>06975358885316</udiDi>
    <basicUdiDi>B-06975358885316</basicUdiDi>
    <tradeName>06975358885316</tradeName>
    <deviceName>Male factor infertility detection kit</deviceName>
    <manufacturerName>Xiamen Biofast Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027220</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021399</emdnCode>
    <emdnDescription>CARDIAC MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04110008</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:29:41.040Z</lastUpdated>
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    <udiDi>06975070762575</udiDi>
    <basicUdiDi>B-06975070762575</basicUdiDi>
    <tradeName>Sharay S100-β (CLIA)</tradeName>
    <deviceName>Sharay S100-β (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021399</emdnCode>
    <emdnDescription>CARDIAC MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18315101</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:38:49.957Z</lastUpdated>
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    <udiDi>06974986813784</udiDi>
    <basicUdiDi>B-06974986813784</basicUdiDi>
    <tradeName>Myoglobin/CK-MB/Troponin I Assay Kit (Fluorescence Immunochromatography)</tradeName>
    <deviceName>Myoglobin/CK-MB/Troponin I Assay Kit (Fluorescence Immunochromatography)</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>W01021399</emdnCode>
    <emdnDescription>CARDIAC MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:21:06.529Z</lastUpdated>
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    <udiDi>06974986813777</udiDi>
    <basicUdiDi>B-06974986813777</basicUdiDi>
    <tradeName>Myoglobin/CK-MB/Troponin I Assay Kit (Fluorescence Immunochromatography)</tradeName>
    <deviceName>Myoglobin/CK-MB/Troponin I Assay Kit (Fluorescence Immunochromatography)</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>W01021399</emdnCode>
    <emdnDescription>CARDIAC MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:21:05.727Z</lastUpdated>
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    <udiDi>06974986813760</udiDi>
    <basicUdiDi>B-06974986813760</basicUdiDi>
    <tradeName>Myoglobin/CK-MB/Troponin I Assay Kit (Fluorescence Immunochromatography)</tradeName>
    <deviceName>Myoglobin/CK-MB/Troponin I Assay Kit (Fluorescence Immunochromatography)</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>W01021399</emdnCode>
    <emdnDescription>CARDIAC MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:21:04.924Z</lastUpdated>
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    <udiDi>06974986813753</udiDi>
    <basicUdiDi>B-06974986813753</basicUdiDi>
    <tradeName>Myoglobin/CK-MB/Troponin I Assay Kit (Fluorescence Immunochromatography)</tradeName>
    <deviceName>Myoglobin/CK-MB/Troponin I Assay Kit (Fluorescence Immunochromatography)</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>W01021399</emdnCode>
    <emdnDescription>CARDIAC MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:21:00.931Z</lastUpdated>
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    <udiDi>06974854621114</udiDi>
    <basicUdiDi>B-06974854621114</basicUdiDi>
    <tradeName>C Reactive Protein/Serum Amyloid A (CRP/SAA) Test</tradeName>
    <deviceName>C Reactive Protein/Serum Amyloid A (CRP/SAA) Test</deviceName>
    <manufacturerName>Beijing Jinwofu Bioengineering Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035739</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021399</emdnCode>
    <emdnDescription>CARDIAC MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2206125</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:56:12.782Z</lastUpdated>
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    <udiDi>06974854621077</udiDi>
    <basicUdiDi>B-06974854621077</basicUdiDi>
    <tradeName>cTnI/CK-MB/Myo Rapid Test</tradeName>
    <deviceName>cTnI/CK-MB/Myo Rapid Test</deviceName>
    <manufacturerName>Beijing Jinwofu Bioengineering Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035739</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021399</emdnCode>
    <emdnDescription>CARDIAC MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P22057</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:54:21.980Z</lastUpdated>
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    <udiDi>06974674891704</udiDi>
    <basicUdiDi>B-06974674891704</basicUdiDi>
    <tradeName>Cardiac Troponin I (cTnI) Detection Kit(Fluorescence Immunoassay)</tradeName>
    <deviceName>Cardiac Troponin I (cTnI) Detection Kit(Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021399</emdnCode>
    <emdnDescription>CARDIAC MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0117</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:12:06.202Z</lastUpdated>
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    <udiDi>06974566303025</udiDi>
    <basicUdiDi>B-06974566303025</basicUdiDi>
    <tradeName>One Step CK MB/Myoglobin/ Troponin I Combo Test</tradeName>
    <deviceName>One Step CK MB/Myoglobin/ Troponin I Combo Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021399</emdnCode>
    <emdnDescription>CARDIAC MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMC-432</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:54:08.143Z</lastUpdated>
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    <udiDi>06974473300575</udiDi>
    <basicUdiDi>B-06974473300575</basicUdiDi>
    <tradeName>hs cTnI /CK-MB/MyoRapid Test Kit (Quantum Dot Fluorescence Immunoassay)</tradeName>
    <deviceName>hs cTnI /CK-MB/MyoRapid Test Kit (Quantum Dot Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021399</emdnCode>
    <emdnDescription>CARDIAC MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XJ008</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:09:59.006Z</lastUpdated>
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    <udiDi>06973861684143</udiDi>
    <basicUdiDi>B-06973861684143</basicUdiDi>
    <tradeName>CK-MB/cTnI/Myo Rapid Test Kit</tradeName>
    <deviceName>CK-MB/cTnI/Myo Rapid Test Kit</deviceName>
    <manufacturerName>Anbio (Xiamen) Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023936</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021399</emdnCode>
    <emdnDescription>CARDIAC MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02002002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:43:08.699Z</lastUpdated>
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    <udiDi>06973841001007</udiDi>
    <basicUdiDi>B-06973841001007</basicUdiDi>
    <tradeName>cTnI/CK-MB/Myo Test Kit (Immunofluorescence)</tradeName>
    <deviceName>cTnI/CK-MB/Myo Test Kit (Immunofluorescence)</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>W01021399</emdnCode>
    <emdnDescription>CARDIAC MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BA0130</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:39:10.451Z</lastUpdated>
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    <udiDi>04050598008687</udiDi>
    <basicUdiDi>B-04050598008687</basicUdiDi>
    <tradeName>Homoarginin ELISA</tradeName>
    <deviceName>Homoarginin ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021399</emdnCode>
    <emdnDescription>CARDIAC MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 7859</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:28.424Z</lastUpdated>
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    <udiDi>04050598001213</udiDi>
    <basicUdiDi>B-04050598001213</basicUdiDi>
    <tradeName>ADMA ELISA</tradeName>
    <deviceName>ADMA ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021399</emdnCode>
    <emdnDescription>CARDIAC MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 7828</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:40:31.024Z</lastUpdated>
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    <basicUdiDi>697846523ProteinC12RJ</basicUdiDi>
    <tradeName>Thrombomodulin Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Thrombomodulin Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021399</emdnCode>
    <emdnDescription>CARDIAC MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×100 test</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:23:01.188Z</lastUpdated>
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    <udiDi>06978465235883</udiDi>
    <basicUdiDi>697846523ProteinC12RJ</basicUdiDi>
    <tradeName>Thrombomodulin Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Thrombomodulin Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021399</emdnCode>
    <emdnDescription>CARDIAC MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:22:55.193Z</lastUpdated>
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