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<eudamedExport entity="devices">
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    <udiDi>D-ECH019121883</udiDi>
    <basicUdiDi>B-ECH019121883</basicUdiDi>
    <tradeName>D-ECH019121883</tradeName>
    <deviceName>5′-Nucleotidase (5'-NT) Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0191218</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:39:58.147Z</lastUpdated>
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  <row>
    <udiDi>D-ECH01912067U</udiDi>
    <basicUdiDi>B-ECH01912067U</basicUdiDi>
    <tradeName>D-ECH01912067U</tradeName>
    <deviceName>Adenosine Deaminase (ADA) Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0191206</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:39:53.341Z</lastUpdated>
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  <row>
    <udiDi>08809446080704</udiDi>
    <basicUdiDi>B-08809446080704</basicUdiDi>
    <tradeName>08809446080704</tradeName>
    <deviceName>careSTART™ G6PD Biosensor Control Level II</deviceName>
    <manufacturerName>WELLS BIO, INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000031789</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BGT-N05082</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:09:57.263Z</lastUpdated>
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    <udiDi>08809446080698</udiDi>
    <basicUdiDi>B-08809446080698</basicUdiDi>
    <tradeName>08809446080698</tradeName>
    <deviceName>careSTART™ G6PD Biosensor Control Level I</deviceName>
    <manufacturerName>WELLS BIO, INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000031789</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BGO-N05082</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:09:56.634Z</lastUpdated>
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  <row>
    <udiDi>08699015281799</udiDi>
    <basicUdiDi>B-08699015281799</basicUdiDi>
    <tradeName>CK-MB KONTROL SEVİYE II</tradeName>
    <deviceName>CK-MB CONTROL LEVEL II</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01R93-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:12:48.494Z</lastUpdated>
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  <row>
    <udiDi>08699015281782</udiDi>
    <basicUdiDi>B-08699015281782</basicUdiDi>
    <tradeName>CK-MB KONTROL SEVİYE I</tradeName>
    <deviceName>CK-MB CONTROL LEVEL I</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01R92-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:12:47.687Z</lastUpdated>
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  <row>
    <udiDi>D-084360388738733K9</udiDi>
    <basicUdiDi>B-084360388738733K9</basicUdiDi>
    <tradeName>CK-NAC/CK-MB Control (Level 2), 1 x 2 mL</tradeName>
    <deviceName>CK-NAC/CK-MB Control (Level 2), 1 x 2 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0762</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:33:25.004Z</lastUpdated>
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  <row>
    <udiDi>D-084360388478473KB</udiDi>
    <basicUdiDi>B-084360388478473KB</basicUdiDi>
    <tradeName>CK-NAC/CK-MB Control (level 1), 1 x 2 mL</tradeName>
    <deviceName>CK-NAC/CK-MB Control (Level 1), 1 x 2 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0697</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:33:12.209Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798100044682</udiDi>
    <basicUdiDi>B-07798100044682</basicUdiDi>
    <tradeName>CK-MB Control 3 niveles</tradeName>
    <deviceName>CK-MB Control 3 niveles</deviceName>
    <manufacturerName>Wiener Laboratorios SAIC</manufacturerName>
    <manufacturerSrn>AR-MF-000023605</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1271553</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:11:12.050Z</lastUpdated>
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  <row>
    <udiDi>00884883005433</udiDi>
    <basicUdiDi>B-00884883005433</basicUdiDi>
    <tradeName>00884883005433</tradeName>
    <deviceName>MAS® Omni-CORE Liquid Assayed Integrated Chemistry Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCR-SP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:22:19.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883005426</udiDi>
    <basicUdiDi>B-00884883005426</basicUdiDi>
    <tradeName>00884883005426</tradeName>
    <deviceName>MAS® Omni-CORE Liquid Assayed Integrated Chemistry Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCR-303</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:22:17.619Z</lastUpdated>
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  <row>
    <udiDi>00884883005419</udiDi>
    <basicUdiDi>B-00884883005419</basicUdiDi>
    <tradeName>00884883005419</tradeName>
    <deviceName>MAS® Omni-CORE Liquid Assayed Integrated Chemistry Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCR-202</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:22:15.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883005402</udiDi>
    <basicUdiDi>B-00884883005402</basicUdiDi>
    <tradeName>00884883005402</tradeName>
    <deviceName>MAS® Omni-CORE Liquid Assayed Integrated Chemistry Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCR-101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:22:13.631Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883003798</udiDi>
    <basicUdiDi>B-00884883003798</basicUdiDi>
    <tradeName>00884883003798</tradeName>
    <deviceName>MAS® ChemTRAK H Unassayed Control Sample Pack</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHU-SP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:18:34.162Z</lastUpdated>
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  <row>
    <udiDi>00884883003781</udiDi>
    <basicUdiDi>B-00884883003781</basicUdiDi>
    <tradeName>00884883003781</tradeName>
    <deviceName>MAS® ChemTRAK H Unassayed Liquid Unassayed Chemistry Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHU-3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:18:33.336Z</lastUpdated>
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  <row>
    <udiDi>00884883003774</udiDi>
    <basicUdiDi>B-00884883003774</basicUdiDi>
    <tradeName>00884883003774</tradeName>
    <deviceName>MAS® ChemTRAK H Unassayed Liquid Unassayed Chemistry Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHU-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:18:32.541Z</lastUpdated>
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    <udiDi>00884883003767</udiDi>
    <basicUdiDi>B-00884883003767</basicUdiDi>
    <tradeName>00884883003767</tradeName>
    <deviceName>MAS® ChemTRAK H Unassayed Liquid Unassayed Chemistry Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHU-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:18:31.735Z</lastUpdated>
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  <row>
    <udiDi>00884883003750</udiDi>
    <basicUdiDi>B-00884883003750</basicUdiDi>
    <tradeName>00884883003750</tradeName>
    <deviceName>MAS® ChemTRAK H Liquid Assayed Chemistry Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHA-SP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:18:27.746Z</lastUpdated>
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    <udiDi>00884883003743</udiDi>
    <basicUdiDi>B-00884883003743</basicUdiDi>
    <tradeName>00884883003743</tradeName>
    <deviceName>MAS® ChemTRAK H Liquid Assayed Chemistry Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHA-3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:18:26.935Z</lastUpdated>
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    <udiDi>00884883003736</udiDi>
    <basicUdiDi>B-00884883003736</basicUdiDi>
    <tradeName>00884883003736</tradeName>
    <deviceName>MAS® ChemTRAK H Liquid Assayed Chemistry Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHA-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:18:26.245Z</lastUpdated>
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</eudamedExport>