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    <basicUdiDi>694490400045CK-MB******U8</basicUdiDi>
    <tradeName>Creatine Kinase-MB Kit (IFCC Method)</tradeName>
    <deviceName>Creatine Kinase-MB Kit (IFCC Method)、CK-MB Calibrator</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010114</emdnCode>
    <emdnDescription>CREATINE KINASE - MB ACTIVITY (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-000870-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:43:43.484Z</lastUpdated>
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  <row>
    <udiDi>03701700819301</udiDi>
    <basicUdiDi>37017008CMSL009T</basicUdiDi>
    <tradeName>CK-MB SL</tradeName>
    <deviceName>CK-MB SL</deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010114</emdnCode>
    <emdnDescription>CREATINE KINASE - MB ACTIVITY (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMSL-0410</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:50:41.932Z</lastUpdated>
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  <row>
    <udiDi>03701700803201</udiDi>
    <basicUdiDi>37017008CMSL039Z</basicUdiDi>
    <tradeName>CK-MB</tradeName>
    <deviceName>CK-MB</deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
    <manufacturerSrn>FR-MF-000004722</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010114</emdnCode>
    <emdnDescription>CREATINE KINASE - MB ACTIVITY (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMSL-0230</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:49:22.918Z</lastUpdated>
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    <udiDi>15099590232368</udiDi>
    <basicUdiDi>150995901AccCKMBXX</basicUdiDi>
    <tradeName>Access CK-MB</tradeName>
    <deviceName>Access CK-MB</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010114</emdnCode>
    <emdnDescription>CREATINE KINASE - MB ACTIVITY (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>386371</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:35:16.595Z</lastUpdated>
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    <udiDi>15099590011468</udiDi>
    <basicUdiDi>150995901OSR61155SZ</basicUdiDi>
    <tradeName>CK-MB</tradeName>
    <deviceName>CK-MB</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010114</emdnCode>
    <emdnDescription>CREATINE KINASE - MB ACTIVITY (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR61155</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:29:22.474Z</lastUpdated>
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    <udiDi>04547410032826</udiDi>
    <basicUdiDi>B-04547410032826</basicUdiDi>
    <tradeName>FUJI DRI-CHEM SLIDE CKMB-P</tradeName>
    <deviceName>FUJI DRI-CHEM SLIDE CKMB-P</deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010114</emdnCode>
    <emdnDescription>CREATINE KINASE - MB ACTIVITY (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04547410032826</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-24T00:29:41.874Z</lastUpdated>
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    <udiDi>08431673939878</udiDi>
    <basicUdiDi>B-08431673939878</basicUdiDi>
    <tradeName>CK-MB-LQ</tradeName>
    <deviceName>Creatine kinase-MB</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010114</emdnCode>
    <emdnDescription>CREATINE KINASE - MB ACTIVITY (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MD41254</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:26:02.594Z</lastUpdated>
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    <udiDi>08431673612559</udiDi>
    <basicUdiDi>B-08431673612559</basicUdiDi>
    <tradeName>CK-MB-LQ</tradeName>
    <deviceName>Creatine kinase-MB</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010114</emdnCode>
    <emdnDescription>CREATINE KINASE - MB ACTIVITY (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TK41255</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:25:15.144Z</lastUpdated>
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    <udiDi>08431673612542</udiDi>
    <basicUdiDi>B-08431673612542</basicUdiDi>
    <tradeName>CK-MB-LQ</tradeName>
    <deviceName>Creatine kinase-MB</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010114</emdnCode>
    <emdnDescription>CREATINE KINASE - MB ACTIVITY (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TK41254</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:25:11.518Z</lastUpdated>
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    <udiDi>08431673512545</udiDi>
    <basicUdiDi>B-08431673512545</basicUdiDi>
    <tradeName>CK-MB-LQ</tradeName>
    <deviceName>Creatine kinase-MB</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010114</emdnCode>
    <emdnDescription>CREATINE KINASE - MB ACTIVITY (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP41254</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:24:36.966Z</lastUpdated>
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    <udiDi>08431673412548</udiDi>
    <basicUdiDi>B-08431673412548</basicUdiDi>
    <tradeName>CK-MB-LQ</tradeName>
    <deviceName>Creatine kinase-MB</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010114</emdnCode>
    <emdnDescription>CREATINE KINASE - MB ACTIVITY (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>41254</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:24:01.042Z</lastUpdated>
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    <udiDi>08431673412555</udiDi>
    <basicUdiDi>B-08431673412555</basicUdiDi>
    <tradeName>CK-MB-LQ</tradeName>
    <deviceName>Creatine kinase-MB</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010114</emdnCode>
    <emdnDescription>CREATINE KINASE - MB ACTIVITY (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>41254C</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:23:58.585Z</lastUpdated>
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  <row>
    <udiDi>08431673090661</udiDi>
    <basicUdiDi>B-08431673090661</basicUdiDi>
    <tradeName>CK-MB-LQ</tradeName>
    <deviceName>Creatine kinase-MB</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010114</emdnCode>
    <emdnDescription>CREATINE KINASE - MB ACTIVITY (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MX41254</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:20:13.750Z</lastUpdated>
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    <udiDi>08431673088071</udiDi>
    <basicUdiDi>B-08431673088071</basicUdiDi>
    <tradeName>CK-MB-LQ</tradeName>
    <deviceName>Creatine kinase-MB</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010114</emdnCode>
    <emdnDescription>CREATINE KINASE - MB ACTIVITY (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JL41254</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:17:00.650Z</lastUpdated>
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    <udiDi>08431673073848</udiDi>
    <basicUdiDi>B-08431673073848</basicUdiDi>
    <tradeName>CK-MB-LQ</tradeName>
    <deviceName>Creatine kinase-MB</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010114</emdnCode>
    <emdnDescription>CREATINE KINASE - MB ACTIVITY (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MI41254</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:15:40.549Z</lastUpdated>
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    <udiDi>08431673010553</udiDi>
    <basicUdiDi>B-08431673010553</basicUdiDi>
    <tradeName>CK-MB</tradeName>
    <deviceName>Creatine kinase-MB</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010114</emdnCode>
    <emdnDescription>CREATINE KINASE - MB ACTIVITY (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001055</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:13:58.786Z</lastUpdated>
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    <udiDi>08431673010546</udiDi>
    <basicUdiDi>B-08431673010546</basicUdiDi>
    <tradeName>CK-MB</tradeName>
    <deviceName>Creatine kinase-MB</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010114</emdnCode>
    <emdnDescription>CREATINE KINASE - MB ACTIVITY (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001054</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:13:57.985Z</lastUpdated>
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    <udiDi>08034063843153</udiDi>
    <basicUdiDi>B-08034063843153</basicUdiDi>
    <tradeName>CK - MB</tradeName>
    <deviceName>CK-MB</deviceName>
    <manufacturerName>FAR Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000041136</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010114</emdnCode>
    <emdnDescription>CREATINE KINASE - MB ACTIVITY (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL18-75</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:22:04.513Z</lastUpdated>
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    <udiDi>62230182721510</udiDi>
    <basicUdiDi>B-62230182721510</basicUdiDi>
    <tradeName>Creatine Kinase MB (CK-MB)</tradeName>
    <deviceName>Creatine Kinase MB (CK-MB)</deviceName>
    <manufacturerName>Kalians Corporation</manufacturerName>
    <manufacturerSrn>EG-MF-000050142</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010114</emdnCode>
    <emdnDescription>CREATINE KINASE - MB ACTIVITY (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-615 002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:38:11.634Z</lastUpdated>
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    <udiDi>62230182721442</udiDi>
    <basicUdiDi>B-62230182721442</basicUdiDi>
    <tradeName>Creatine Kinase MB (CK-MB)</tradeName>
    <deviceName>Creatine Kinase MB (CK-MB)</deviceName>
    <manufacturerName>Kalians Corporation</manufacturerName>
    <manufacturerSrn>EG-MF-000050142</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010114</emdnCode>
    <emdnDescription>CREATINE KINASE - MB ACTIVITY (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-615 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:38:10.846Z</lastUpdated>
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