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    <tradeName>RapidFor™Myoglobin Rapid Test Kit (FIA)</tradeName>
    <deviceName>Myoglobin Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160702</emdnCode>
    <emdnDescription>MYOGLOBIN - RT &amp; POC</emdnDescription>
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    <reference>VMPO12</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:09:28.182Z</lastUpdated>
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    <udiDi>08683347941612</udiDi>
    <basicUdiDi>B-08683347941612</basicUdiDi>
    <tradeName>RapidFor™ Myo + CK-MB + Troponin I Combo Rapid Test Kit</tradeName>
    <deviceName>Myo + CK-MB + Troponin I Combo Rapid Test Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>CARDIAC MARKERS - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-08T21:05:08.096Z</lastUpdated>
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    <udiDi>08683347941605</udiDi>
    <basicUdiDi>B-08683347941605</basicUdiDi>
    <tradeName>RapidFor™ NT-proBNP Rapid Test Kit</tradeName>
    <deviceName>NT-proBNP Rapid Test Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
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    <emdnDescription>BNP / PROBNP - RT &amp; POC (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
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    <udiDi>08683347941599</udiDi>
    <basicUdiDi>B-08683347941599</basicUdiDi>
    <tradeName>RapidFor™ H-FABP Rapid Test Kit</tradeName>
    <deviceName>H-FABP Rapid Test Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160705</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID-BINDING PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMD53</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:05:00.022Z</lastUpdated>
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    <udiDi>08683347941575</udiDi>
    <basicUdiDi>B-08683347941575</basicUdiDi>
    <tradeName>RapidFor™ CK-MB Rapid Test Kit</tradeName>
    <deviceName>CK-MB Rapid Test Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160799</emdnCode>
    <emdnDescription>CARDIAC MARKERS - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMD51</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:04:58.420Z</lastUpdated>
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    <udiDi>08683347941568</udiDi>
    <basicUdiDi>B-08683347941568</basicUdiDi>
    <tradeName>RapidFor™ Myoglobin Rapid Test Kit</tradeName>
    <deviceName>Myoglobin Rapid Test Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160702</emdnCode>
    <emdnDescription>MYOGLOBIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMD50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:04:53.611Z</lastUpdated>
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    <udiDi>08683347941551</udiDi>
    <basicUdiDi>B-08683347941551</basicUdiDi>
    <tradeName>RapidFor™ Troponin I Rapid Test Kit</tradeName>
    <deviceName>RapidFor™ Troponin I Rapid Test Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160703</emdnCode>
    <emdnDescription>TROPONIN I/T - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMD49</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:04:52.815Z</lastUpdated>
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    <udiDi>08445982001003</udiDi>
    <basicUdiDi>B-08445982001003</basicUdiDi>
    <tradeName>Qassay Troponin I Professional Test</tradeName>
    <deviceName>Qassay Troponin I Professional Test</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160703</emdnCode>
    <emdnDescription>TROPONIN I/T - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:06:10.328Z</lastUpdated>
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    <udiDi>06978896416028</udiDi>
    <basicUdiDi>B-06978896416028</basicUdiDi>
    <tradeName>06978896416028</tradeName>
    <deviceName>B-type natriuretic peptide (BNP) 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>W0102160704</emdnCode>
    <emdnDescription>BNP / PROBNP - RT &amp; POC (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF2-BNP-40</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:49:59.902Z</lastUpdated>
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    <udiDi>06978896416011</udiDi>
    <basicUdiDi>B-06978896416011</basicUdiDi>
    <tradeName>06978896416011</tradeName>
    <deviceName>B-type natriuretic peptide (BNP) 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>W0102160704</emdnCode>
    <emdnDescription>BNP / PROBNP - RT &amp; POC (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF2-BNP-20</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:49:59.100Z</lastUpdated>
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    <udiDi>06978896415984</udiDi>
    <basicUdiDi>B-06978896415984</basicUdiDi>
    <tradeName>06978896415984</tradeName>
    <deviceName>Myoglobin (MYO) 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>W0102160702</emdnCode>
    <emdnDescription>MYOGLOBIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF2-MYO-40</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:49:55.096Z</lastUpdated>
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    <udiDi>06978896415977</udiDi>
    <basicUdiDi>B-06978896415977</basicUdiDi>
    <tradeName>06978896415977</tradeName>
    <deviceName>Myoglobin (MYO) 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>W0102160702</emdnCode>
    <emdnDescription>MYOGLOBIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF2-MYO-20</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:49:53.276Z</lastUpdated>
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    <udiDi>06978896415946</udiDi>
    <basicUdiDi>B-06978896415946</basicUdiDi>
    <tradeName>06978896415946</tradeName>
    <deviceName>Creatine Kinase Isoenzymes (CK-MB) 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>W0102160701</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF2-CK-MB-40</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:49:34.220Z</lastUpdated>
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    <udiDi>06978896415939</udiDi>
    <basicUdiDi>B-06978896415939</basicUdiDi>
    <tradeName>06978896415939</tradeName>
    <deviceName>Creatine Kinase Isoenzymes (CK-MB) 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>W0102160701</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF2-CK-MB-20</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:49:31.825Z</lastUpdated>
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    <udiDi>06978896415472</udiDi>
    <basicUdiDi>B-06978896415472</basicUdiDi>
    <tradeName>High-Sensitivity Cardiac Troponin I (hs-cTnI) Test Kit (Immunofluorescence Method)</tradeName>
    <deviceName>High-Sensitivity Cardiac Troponin I (hs-cTnI) 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>W0102160703</emdnCode>
    <emdnDescription>TROPONIN I/T - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF2-cTnI-40</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:48:05.297Z</lastUpdated>
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    <udiDi>06978896415465</udiDi>
    <basicUdiDi>B-06978896415465</basicUdiDi>
    <tradeName>High-Sensitivity Cardiac Troponin I (hs-cTnI) Test Kit (Immunofluorescence Method)</tradeName>
    <deviceName>High-Sensitivity Cardiac Troponin I (hs-cTnI) 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>W0102160703</emdnCode>
    <emdnDescription>TROPONIN I/T - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF2-cTnI-20</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:48:04.498Z</lastUpdated>
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    <basicUdiDi>B-06978896415458</basicUdiDi>
    <tradeName>N-terminal pro-brain Natriuretic Peptide (NT-proBNP) Test Kit (Immunofluorescence Method)</tradeName>
    <deviceName>N-terminal pro-brain Natriuretic Peptide (NT-proBNP) 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>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160704</emdnCode>
    <emdnDescription>BNP / PROBNP - RT &amp; POC (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF2-NT-proBNP-20</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:48:03.691Z</lastUpdated>
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    <basicUdiDi>B-06978896415441</basicUdiDi>
    <tradeName>N-terminal pro-brain Natriuretic Peptide (NT-proBNP) Test Kit (Immunofluorescence Method)</tradeName>
    <deviceName>N-terminal pro-brain Natriuretic Peptide (NT-proBNP) 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>W0102160704</emdnCode>
    <emdnDescription>BNP / PROBNP - RT &amp; POC (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF2-NT-proBNP-20</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:47:59.683Z</lastUpdated>
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    <basicUdiDi>B-06978189071316</basicUdiDi>
    <tradeName>06978189071316</tradeName>
    <deviceName>High-Sensitivity Cardiac Troponin I (hs-cTnI) Test Kit</deviceName>
    <manufacturerName>Yantai JIEZI Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044146</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160703</emdnCode>
    <emdnDescription>TROPONIN I/T - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>High-Sensitivity Cardiac Troponin I (hs-cTnI) Test Kit</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:42:09.319Z</lastUpdated>
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    <basicUdiDi>B-06978189071217</basicUdiDi>
    <tradeName>06978189071217</tradeName>
    <deviceName>High-Sensitivity Cardiac Troponin T (hs-cTnT) Test Kit</deviceName>
    <manufacturerName>Yantai JIEZI Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044146</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160703</emdnCode>
    <emdnDescription>TROPONIN I/T - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:42:07.716Z</lastUpdated>
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