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<eudamedExport entity="devices">
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    <udiDi>D-77967KR</udiDi>
    <basicUdiDi>B-77967KR</basicUdiDi>
    <tradeName>SPOTCHEM Electrolyte Control [Na, K, Cl]</tradeName>
    <deviceName>SPOTCHEM Electrolyte Control [Na, K, Cl]</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050204</emdnCode>
    <emdnDescription>ELECTROLYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>77967</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:25:22.867Z</lastUpdated>
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    <udiDi>42625753900610</udiDi>
    <basicUdiDi>B-42625753900610</basicUdiDi>
    <tradeName>Trilevel Quality Controls (For Z-Elite Pro+)</tradeName>
    <deviceName>Trilevel Quality Controls (For Z-Elite Pro+)</deviceName>
    <manufacturerName>ZOVEC diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035393</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050204</emdnCode>
    <emdnDescription>ELECTROLYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZA-EC6-P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:42:25.602Z</lastUpdated>
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    <udiDi>42625753900306</udiDi>
    <basicUdiDi>B-42625753900306</basicUdiDi>
    <tradeName>Quality Control Kit</tradeName>
    <deviceName>Quality Control Kit</deviceName>
    <manufacturerName>ZOVEC diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035393</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050204</emdnCode>
    <emdnDescription>ELECTROLYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZA-EC2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:42:23.193Z</lastUpdated>
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    <udiDi>15065023763976</udiDi>
    <basicUdiDi>B-15065023763976</basicUdiDi>
    <tradeName>TruLyta</tradeName>
    <deviceName>Electrolyte control</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050204</emdnCode>
    <emdnDescription>ELECTROLYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TL10003</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:36:48.416Z</lastUpdated>
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    <udiDi>06975200381157</udiDi>
    <basicUdiDi>B-06975200381157</basicUdiDi>
    <tradeName>06975200381157</tradeName>
    <deviceName>Electrolyte Multiple Quality Control</deviceName>
    <manufacturerName>Shenzhen Xilaiheng Medical Electronics Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047090</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050204</emdnCode>
    <emdnDescription>ELECTROLYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Q301</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:07:57.192Z</lastUpdated>
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    <udiDi>06972337850150</udiDi>
    <basicUdiDi>B-06972337850150</basicUdiDi>
    <tradeName>06972337850150</tradeName>
    <deviceName>Electrolyte Control</deviceName>
    <manufacturerName>B&amp;E BIO-TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000023256</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050204</emdnCode>
    <emdnDescription>ELECTROLYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QC-5  low：2.0mL×5、normal：2.0mL×5、high：2.0mL×5</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:49:02.064Z</lastUpdated>
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  <row>
    <udiDi>03661540304361</udiDi>
    <basicUdiDi>B-03661540304361</basicUdiDi>
    <tradeName>Sweat Controls, L1, L2, L3</tradeName>
    <deviceName>Sweat Controls; L1,L2,L3</deviceName>
    <manufacturerName>ELITechGroup Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006942</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050204</emdnCode>
    <emdnDescription>ELECTROLYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS-150</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T14:16:59.464Z</lastUpdated>
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  <row>
    <udiDi>89061707102258</udiDi>
    <basicUdiDi>890617071AVMEQCK8</basicUdiDi>
    <tradeName>MAXLYTE</tradeName>
    <deviceName>Maxlyte 3 Level Quality Control</deviceName>
    <manufacturerName>Avecon Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000040691</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050204</emdnCode>
    <emdnDescription>ELECTROLYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVMEQC-12</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:50:38.044Z</lastUpdated>
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  <row>
    <udiDi>08806712905723</udiDi>
    <basicUdiDi>8806712POCEQC001HW</basicUdiDi>
    <tradeName>i-Smart Electrolyte Quality Control</tradeName>
    <deviceName>i-Smart Electrolyte Quality Control</deviceName>
    <manufacturerName>i-SENS, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009173</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050204</emdnCode>
    <emdnDescription>ELECTROLYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCEQC001</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:43:43.449Z</lastUpdated>
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  <row>
    <udiDi>06972873821003</udiDi>
    <basicUdiDi>697287382EQCVW</basicUdiDi>
    <tradeName>06972873821003</tradeName>
    <deviceName>Electrolytes Quality Control</deviceName>
    <manufacturerName>Shenzhen Cornley Bio-Medical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017322</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050204</emdnCode>
    <emdnDescription>ELECTROLYTE CONTROLS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:19:16.387Z</lastUpdated>
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  <row>
    <udiDi>06935740739597</udiDi>
    <basicUdiDi>69357407ICAS000040AS</basicUdiDi>
    <tradeName>06935740739597</tradeName>
    <deviceName>ISE Quality Control Material</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050204</emdnCode>
    <emdnDescription>ELECTROLYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:04:27.396Z</lastUpdated>
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  <row>
    <udiDi>08806712905730</udiDi>
    <basicUdiDi>8806712POCEQC001HW</basicUdiDi>
    <tradeName>i-Smart Electrolyte Quality Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>i-SENS, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009173</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050204</emdnCode>
    <emdnDescription>ELECTROLYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCEQC001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T03:37:13.595Z</lastUpdated>
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    <udiDi>08058056682895</udiDi>
    <basicUdiDi>805805668CIAMMO01ZZ018NQK</basicUdiDi>
    <tradeName>Ammonia Controls</tradeName>
    <deviceName>Ammonia</deviceName>
    <manufacturerName>SENTINEL CH. S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000012556</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050204</emdnCode>
    <emdnDescription>ELECTROLYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6K89-20</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:13:45.186Z</lastUpdated>
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  <row>
    <udiDi>06944413847576</udiDi>
    <basicUdiDi>B-06944413847576</basicUdiDi>
    <tradeName>Controls</tradeName>
    <deviceName>Controls</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050204</emdnCode>
    <emdnDescription>ELECTROLYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CO-Oximeter Control Level 3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:42:33.290Z</lastUpdated>
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  <row>
    <udiDi>06944413847569</udiDi>
    <basicUdiDi>B-06944413847569</basicUdiDi>
    <tradeName>Controls</tradeName>
    <deviceName>Controls</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050204</emdnCode>
    <emdnDescription>ELECTROLYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CO-Oximeter Control Level 2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:42:32.022Z</lastUpdated>
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    <udiDi>06944413847552</udiDi>
    <basicUdiDi>B-06944413847552</basicUdiDi>
    <tradeName>Controls</tradeName>
    <deviceName>Controls</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050204</emdnCode>
    <emdnDescription>ELECTROLYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CO-Oximeter Control Level 1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:42:30.950Z</lastUpdated>
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    <udiDi>06944413847538</udiDi>
    <basicUdiDi>B-06944413847538</basicUdiDi>
    <tradeName>Controls</tradeName>
    <deviceName>Controls</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050204</emdnCode>
    <emdnDescription>ELECTROLYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Blood Gas and Electrolyte Control Level 3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:42:29.627Z</lastUpdated>
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    <udiDi>06944413847521</udiDi>
    <basicUdiDi>B-06944413847521</basicUdiDi>
    <tradeName>Controls</tradeName>
    <deviceName>Controls</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050204</emdnCode>
    <emdnDescription>ELECTROLYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Blood Gas and Electrolyte Control Level 2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:42:23.609Z</lastUpdated>
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    <udiDi>06944413847514</udiDi>
    <basicUdiDi>B-06944413847514</basicUdiDi>
    <tradeName>Controls</tradeName>
    <deviceName>Controls</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050204</emdnCode>
    <emdnDescription>ELECTROLYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Blood Gas and Electrolyte Control Level 1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:42:22.504Z</lastUpdated>
  </row>
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    <udiDi>06944413815674</udiDi>
    <basicUdiDi>B-06944413815674</basicUdiDi>
    <tradeName>Controls</tradeName>
    <deviceName>Controls</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050204</emdnCode>
    <emdnDescription>ELECTROLYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CO-Oximeter Control Level 3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:17:26.604Z</lastUpdated>
  </row>
</eudamedExport>