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<eudamedExport entity="devices">
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    <udiDi>08885013953718</udiDi>
    <basicUdiDi>B-08885013953718</basicUdiDi>
    <tradeName>Sentosa SA CMV Controls Set (8x3)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T04:07:22.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885013953725</udiDi>
    <basicUdiDi>B-08885013953725</basicUdiDi>
    <tradeName>Sentosa SA VZV PCR Test (4x48)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T04:07:22.656Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885013953732</udiDi>
    <basicUdiDi>B-08885013953732</basicUdiDi>
    <tradeName>Sentosa SA VZV Controls (8x3)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T04:07:22.645Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885013953787</udiDi>
    <basicUdiDi>B-08885013953787</basicUdiDi>
    <tradeName>Sentosa SA HHV6 Controls Set (8x3)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T04:07:22.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885013953824</udiDi>
    <basicUdiDi>B-08885013953824</basicUdiDi>
    <tradeName>ViroKey SARS-CoV-2 RT-PCR Test v2.0 (8x48)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T04:07:22.609Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885013953862</udiDi>
    <basicUdiDi>B-08885013953862</basicUdiDi>
    <tradeName>ViroKey SARS-CoV-2 RT-PCR Test v2.0 (4x96)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T04:07:22.588Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885013953978</udiDi>
    <basicUdiDi>B-08885013953978</basicUdiDi>
    <tradeName>Sentosa SA RSV RT-PCR Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T04:07:22.559Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885013953985</udiDi>
    <basicUdiDi>B-08885013953985</basicUdiDi>
    <tradeName>Sentosa SA ZIKV RT-PCR Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T04:07:22.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885013956061</udiDi>
    <basicUdiDi>B-08885013956061</basicUdiDi>
    <tradeName>Sentosa SQ NSCLC Panel (4x8)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T04:07:22.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885013956085</udiDi>
    <basicUdiDi>B-08885013956085</basicUdiDi>
    <tradeName>Sentosa SQ CRC Panel (4x8)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T04:07:22.515Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885013956252</udiDi>
    <basicUdiDi>888501395SSQ301P2E</basicUdiDi>
    <tradeName>Sentosa SQ Sequencing Kit (8)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T04:07:22.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885013956290</udiDi>
    <basicUdiDi>888501395SSQ301P2E</basicUdiDi>
    <tradeName>Sentosa SQ 318 Chip Kit (8)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T04:07:22.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885013956634</udiDi>
    <basicUdiDi>B-08885013956634</basicUdiDi>
    <tradeName>ViroKey SARS-CoV-2 RT-PCR Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T04:07:22.464Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885013953046</udiDi>
    <basicUdiDi>B-08885013953046</basicUdiDi>
    <tradeName>Sentosa SA C. diff PCR Test v2.0 (4x24)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T23:54:59.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885013953077</udiDi>
    <basicUdiDi>B-08885013953077</basicUdiDi>
    <tradeName>Sentosa SA Direct MRSA/SA PCR Test (4x24)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T23:54:59.174Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885013953121</udiDi>
    <basicUdiDi>B-08885013953121</basicUdiDi>
    <tradeName>Sentosa SA Dengue I-IV RT-PCR Test (4x8)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T23:54:59.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885013953305</udiDi>
    <basicUdiDi>B-08885013953305</basicUdiDi>
    <tradeName>Sentosa SA HSV1/2 Quantitation Standards (2x13)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T23:54:59.136Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885013953367</udiDi>
    <basicUdiDi>B-08885013953367</basicUdiDi>
    <tradeName>Sentosa SA VZV Quantitation Standards (2x13)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T23:54:59.121Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885013956108</udiDi>
    <basicUdiDi>B-08885013956108</basicUdiDi>
    <tradeName>Sentosa SQ Thyroid Cancer Panel (4x8)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T23:54:59.093Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885013958218</udiDi>
    <basicUdiDi>888501395VKVTNA2S</basicUdiDi>
    <tradeName>ViroKey SX Virus Total Nucleic Acid (4x48)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T23:54:59.001Z</lastUpdated>
  </row>
</eudamedExport>