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<eudamedExport entity="devices">
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    <udiDi>00812117015231</udiDi>
    <basicUdiDi>081211701LSLJ</basicUdiDi>
    <tradeName>PE Conjugated Goat Anti-Human IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01030402</emdnCode>
    <emdnDescription>HLA ANTIBODY SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LS-AB2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T04:10:56.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812117015224</udiDi>
    <basicUdiDi>081211701LSLJ</basicUdiDi>
    <tradeName>LABScreen™ Negative Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01030402</emdnCode>
    <emdnDescription>HLA ANTIBODY SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LS-NC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T04:10:52.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>00814695025961</udiDi>
    <basicUdiDi>081211701LSLJ</basicUdiDi>
    <tradeName>LABScreen™ Single Antigen HLA Class II ExPlex - Group 2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01030402</emdnCode>
    <emdnDescription>HLA ANTIBODY SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LS2AEX02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-17T03:49:03.420Z</lastUpdated>
  </row>
  <row>
    <udiDi>00814695021697</udiDi>
    <basicUdiDi>081469502SECGZ</basicUdiDi>
    <tradeName>SeCore™ A Locus Sequencing Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5300025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:37:32.722Z</lastUpdated>
  </row>
  <row>
    <udiDi>00814695022823</udiDi>
    <basicUdiDi>081469502SECGZ</basicUdiDi>
    <tradeName>SeCore™ A Locus Sequencing Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22000D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:37:32.687Z</lastUpdated>
  </row>
  <row>
    <udiDi>00814695022830</udiDi>
    <basicUdiDi>081469502SECGZ</basicUdiDi>
    <tradeName>SeCore™ B Locus Sequencing Kit, Single Amplification</tradeName>
    <deviceName></deviceName>
    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22110D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:37:32.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>00814695022854</udiDi>
    <basicUdiDi>081469502SECGZ</basicUdiDi>
    <tradeName>SeCore™ B Locus Sequencing Kit, Single Amplification</tradeName>
    <deviceName></deviceName>
    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5311025D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:37:32.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>00814695024445</udiDi>
    <basicUdiDi>081469502TSVKN</basicUdiDi>
    <tradeName>TypeStream™ Visual Software version 3.2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MICRO-ARRAY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TSVPGR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:37:32.602Z</lastUpdated>
  </row>
  <row>
    <udiDi>00814695024933</udiDi>
    <basicUdiDi>081469502STPK8</basicUdiDi>
    <tradeName>SureTyper™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STTPGRX</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:37:32.571Z</lastUpdated>
  </row>
  <row>
    <udiDi>00814695025251</udiDi>
    <basicUdiDi>081469502LNQHM</basicUdiDi>
    <tradeName>LinkSēq HLA-ABCDRDQB1 Typing Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1054C-ABS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:37:32.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>00814695025268</udiDi>
    <basicUdiDi>081469502LNQHM</basicUdiDi>
    <tradeName>LinkSēq HLA-ABCDRDQB1 Typing Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1054C-RLC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:37:32.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>00814695025299</udiDi>
    <basicUdiDi>081469502LNQHM</basicUdiDi>
    <tradeName>LinkSēq HLA-ABCDRDQA1DQB1 384 Typing Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1550C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:37:32.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>00814695025312</udiDi>
    <basicUdiDi>081469502LNQHM</basicUdiDi>
    <tradeName>LinkSēq HLA-ABCDRDQB1 384 Typing Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1551C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:37:32.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>00814695025336</udiDi>
    <basicUdiDi>081469502LNQHM</basicUdiDi>
    <tradeName>LinkSēq HLA-ABCDRDQB1 384 Typing Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1554C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:37:32.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>00814695025350</udiDi>
    <basicUdiDi>081469502LNQHM</basicUdiDi>
    <tradeName>LinkSēq HLA-ABCDRDQDP+ 384 Typing Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1575C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:37:32.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>00814695025374</udiDi>
    <basicUdiDi>081469502LNQHM</basicUdiDi>
    <tradeName>LinkSēq HLA-ABCDRDQDP SABR 384 Typing Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1580C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:37:32.385Z</lastUpdated>
  </row>
  <row>
    <udiDi>00814695025398</udiDi>
    <basicUdiDi>081469502LNQHM</basicUdiDi>
    <tradeName>LinkSēq HLA-ABC 384 Typing Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1821C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:37:32.355Z</lastUpdated>
  </row>
  <row>
    <udiDi>00814695025411</udiDi>
    <basicUdiDi>081469502LNQHM</basicUdiDi>
    <tradeName>LinkSēq HLA-ABC 384 Typing Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1822C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:37:32.328Z</lastUpdated>
  </row>
  <row>
    <udiDi>00814695025435</udiDi>
    <basicUdiDi>081469502LNQHM</basicUdiDi>
    <tradeName>LinkSēq HLA-DRDQDP 384 Typing Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1861C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:37:32.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>00814695025459</udiDi>
    <basicUdiDi>081469502LNQHM</basicUdiDi>
    <tradeName>LinkSēq HLA-DRDQDP 384 Typing Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>One Lambda, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024901</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HLA ANTIGEN TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1862C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:37:32.266Z</lastUpdated>
  </row>
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