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<eudamedExport entity="devices">
  <row>
    <udiDi>08904226008869</udiDi>
    <basicUdiDi>8904226058IC104WS</basicUdiDi>
    <tradeName>Crystal</tradeName>
    <deviceName>Crystal® Dengue IgG/IgM</deviceName>
    <manufacturerName>ARKRAY Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000019015</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>58IC104-25, 58IC104-50</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T06:20:46.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904226008845</udiDi>
    <basicUdiDi>8904226058IC106WW</basicUdiDi>
    <tradeName>Crystal</tradeName>
    <deviceName>Crystal Dengue Duo</deviceName>
    <manufacturerName>ARKRAY Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000019015</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>58IC106-10, 58IC106-25, 58IC106-50</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T06:20:44.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904226008821</udiDi>
    <basicUdiDi>8904226058IC102WN</basicUdiDi>
    <tradeName>Crystal</tradeName>
    <deviceName>Crystal Dengue NS1</deviceName>
    <manufacturerName>ARKRAY Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000019015</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>58IC102-10, 58IC102-25, 58IC102-50</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T06:20:43.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904226008289</udiDi>
    <basicUdiDi>8904226016IC101TN</basicUdiDi>
    <tradeName>Crystal</tradeName>
    <deviceName>Immunochromatographic One Step Rapid Visual Test for Vibrio cholerae – Dipstick</deviceName>
    <manufacturerName>ARKRAY Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000019015</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16IC101-50</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T06:20:37.699Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904226003437</udiDi>
    <basicUdiDi>8904226085LS2003P</basicUdiDi>
    <tradeName>AUTOSPAN</tradeName>
    <deviceName>AUTOSPAN® Liquid Gold Creatinine</deviceName>
    <manufacturerName>ARKRAY Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000019015</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010207</emdnCode>
    <emdnDescription>CREATININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>85LS200-60</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T06:20:36.502Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904226003413</udiDi>
    <basicUdiDi>8904226084LS10035</basicUdiDi>
    <tradeName>AUTOSPAN</tradeName>
    <deviceName>AUTOSPAN Liquid Gold A lbumin Bromocresol Green, End Point Assay.</deviceName>
    <manufacturerName>ARKRAY Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000019015</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010201</emdnCode>
    <emdnDescription>ALBUMIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>84LS100-60</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T06:20:35.302Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904226003253</udiDi>
    <basicUdiDi>8904226079LS2004S</basicUdiDi>
    <tradeName>AUTOSPAN</tradeName>
    <deviceName>AUTOSPAN® Liquid Gold α-AMYLASE</deviceName>
    <manufacturerName>ARKRAY Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000019015</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010108</emdnCode>
    <emdnDescription>AMYLASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>79LS200-05, 79LS200-10</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T06:20:34.098Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904226002942</udiDi>
    <basicUdiDi>8904226071LS200ZF</basicUdiDi>
    <tradeName>AUTOSPAN</tradeName>
    <deviceName>AUTOSPAN® Liquid Gold Cholesterol</deviceName>
    <manufacturerName>ARKRAY Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000019015</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010205</emdnCode>
    <emdnDescription>CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>71LS200-40, 71LS200-60, 71LS200-75</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T06:20:28.092Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904226002348</udiDi>
    <basicUdiDi>8904226055IC104VK</basicUdiDi>
    <tradeName>ParaHIT</tradeName>
    <deviceName>PARAHIT-F VER. 1.0 Rapid Test for P. falciparum Malaria Device</deviceName>
    <manufacturerName>ARKRAY Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000019015</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55IC104-25, 55IC104-50</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T06:20:26.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904226001457</udiDi>
    <basicUdiDi>8904226041LA300U3</basicUdiDi>
    <tradeName>08904226001457</tradeName>
    <deviceName>ASO Antistreptolysin ‘O’ Latex Test Kit</deviceName>
    <manufacturerName>ARKRAY Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000019015</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>41LA300-20</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T06:20:25.690Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904226001433</udiDi>
    <basicUdiDi>8904226041LA100TR</basicUdiDi>
    <tradeName>08904226001433</tradeName>
    <deviceName>Rheumatoid Factor Latex Test kit</deviceName>
    <manufacturerName>ARKRAY Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000019015</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>41LA100-20</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T06:20:24.492Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904226000719</udiDi>
    <basicUdiDi>8904226016IC211TW</basicUdiDi>
    <tradeName>Crystal</tradeName>
    <deviceName>Crystal® VC - O1</deviceName>
    <manufacturerName>ARKRAY Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000019015</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16IC211-10</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T06:20:18.481Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904226000023</udiDi>
    <basicUdiDi>8904226096MB100YZ</basicUdiDi>
    <tradeName>08904226000023</tradeName>
    <deviceName>MBK G6PD</deviceName>
    <manufacturerName>ARKRAY Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000019015</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>96MB100-10, 96MB100-10CC</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T06:20:17.388Z</lastUpdated>
  </row>
</eudamedExport>