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<eudamedExport entity="devices">
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    <basicUdiDi>6970341680112200GR</basicUdiDi>
    <tradeName>Warming Blanket</tradeName>
    <deviceName>Warming Blanket</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T030301</emdnCode>
    <emdnDescription>AIR FLOW BLANKETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LW-150</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:59:52.784Z</lastUpdated>
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    <udiDi>06970341688394</udiDi>
    <basicUdiDi>6970341680112200GR</basicUdiDi>
    <tradeName>Warming Blanket</tradeName>
    <deviceName>Warming Blanket</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T030301</emdnCode>
    <emdnDescription>AIR FLOW BLANKETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UP-121</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:59:49.279Z</lastUpdated>
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    <udiDi>06970341688196</udiDi>
    <basicUdiDi>69703416803208007JW</basicUdiDi>
    <tradeName>06970341688196</tradeName>
    <deviceName>Nucleic Acid Extraction Reagent (Swab)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>529005</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:59:44.377Z</lastUpdated>
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    <udiDi>06970341688189</udiDi>
    <basicUdiDi>69703416803208006JU</basicUdiDi>
    <tradeName>06970341688189</tradeName>
    <deviceName>Nucleic Acid Extraction Reagent (Swab)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>529004</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:59:40.786Z</lastUpdated>
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    <udiDi>06970341688172</udiDi>
    <basicUdiDi>69703416803208005JS</basicUdiDi>
    <tradeName>06970341688172</tradeName>
    <deviceName>Nucleic Acid Extraction Reagent (Swab)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>529007</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:59:39.611Z</lastUpdated>
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  <row>
    <udiDi>06970341688165</udiDi>
    <basicUdiDi>69703416803208004JQ</basicUdiDi>
    <tradeName>06970341688165</tradeName>
    <deviceName>Nucleic Acid Extraction Reagent (Swab)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>529006</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:59:35.993Z</lastUpdated>
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    <udiDi>06970341688158</udiDi>
    <basicUdiDi>69703416803208003JN</basicUdiDi>
    <tradeName>06970341688158</tradeName>
    <deviceName>Nucleic Acid Extraction Reagent (Swab)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>529021</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:59:32.487Z</lastUpdated>
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  <row>
    <udiDi>06970341688141</udiDi>
    <basicUdiDi>B-06970341688141</basicUdiDi>
    <tradeName>06970341688141</tradeName>
    <deviceName>SARS-CoV-2 Nucleic Acid Detection Kit (Multiplex PCR Fluorescent Probe Method)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>528007</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:59:28.780Z</lastUpdated>
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  <row>
    <udiDi>06970341688134</udiDi>
    <basicUdiDi>B-06970341688134</basicUdiDi>
    <tradeName>06970341688134</tradeName>
    <deviceName>SARS-CoV-2 Nucleic Acid Detection Kit (Multiplex PCR Fluorescent Probe Method)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>528006</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:59:27.571Z</lastUpdated>
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  <row>
    <udiDi>06970341688110</udiDi>
    <basicUdiDi>B-06970341688110</basicUdiDi>
    <tradeName>Procollagen III N-terminal peptide (PIIINP) eCLIA</tradeName>
    <deviceName>Procollagen III N-terminal peptide (PIIINP) eCLIA</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102120104</emdnCode>
    <emdnDescription>PROCOLLAGEN III AMINO TERMINAL PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>692011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:59:21.576Z</lastUpdated>
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  <row>
    <udiDi>06970341688103</udiDi>
    <basicUdiDi>B-06970341688103</basicUdiDi>
    <tradeName>Pepsinogen II (Electrochemiluminescence Immunoassay)</tradeName>
    <deviceName>Pepsinogen II (Electrochemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>696025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:59:17.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970341688097</udiDi>
    <basicUdiDi>B-06970341688097</basicUdiDi>
    <tradeName>Pepsinogen I (Electrochemiluminescence Immunoassay)</tradeName>
    <deviceName>Pepsinogen I (Electrochemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>696023</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:59:16.868Z</lastUpdated>
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  <row>
    <udiDi>06970341688080</udiDi>
    <basicUdiDi>B-06970341688080</basicUdiDi>
    <tradeName>Laminin (LN) eCLIA</tradeName>
    <deviceName>Laminin (LN) eCLIA</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039006</emdnCode>
    <emdnDescription>LAMININ</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>692017</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:59:13.161Z</lastUpdated>
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  <row>
    <udiDi>06970341688004</udiDi>
    <basicUdiDi>B-06970341688004</basicUdiDi>
    <tradeName>Cholylglycine (CG) eCLIA</tradeName>
    <deviceName>Cholylglycine (CG) eCLIA</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>692015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:58:52.755Z</lastUpdated>
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    <udiDi>06970341687991</udiDi>
    <basicUdiDi>B-06970341687991</basicUdiDi>
    <tradeName>Collagen Type IV (CIV) eCLIA</tradeName>
    <deviceName>Collagen Type IV (CIV) eCLIA</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102120199</emdnCode>
    <emdnDescription>LIVER FUNCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>692013</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:58:49.156Z</lastUpdated>
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  <row>
    <udiDi>06970341686406</udiDi>
    <basicUdiDi>69703416803202004HE</basicUdiDi>
    <tradeName>06970341686406</tradeName>
    <deviceName>Hb NEXT T80 eluent C</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55046</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:58:44.352Z</lastUpdated>
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    <udiDi>06970341686390</udiDi>
    <basicUdiDi>69703416803202003HC</basicUdiDi>
    <tradeName>06970341686390</tradeName>
    <deviceName>Hb NEXT V80 eluent C</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55045</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:58:41.961Z</lastUpdated>
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    <udiDi>06970341686383</udiDi>
    <basicUdiDi>69703416803202002HA</basicUdiDi>
    <tradeName>06970341686383</tradeName>
    <deviceName>Hb NEXT VT80 eluent B</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55044</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:58:38.350Z</lastUpdated>
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    <udiDi>06970341686376</udiDi>
    <basicUdiDi>69703416803202001H8</basicUdiDi>
    <tradeName>06970341686376</tradeName>
    <deviceName>Hb NEXT VT80 eluent A</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320200912</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:58:35.962Z</lastUpdated>
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    <udiDi>06970341686253</udiDi>
    <basicUdiDi>6970341680112100GL</basicUdiDi>
    <tradeName>Sleeve</tradeName>
    <deviceName>Sleeve</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040285</emdnCode>
    <emdnDescription>GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAP-LG-M</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:58:34.746Z</lastUpdated>
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