<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>M7490081971</udiDi>
    <basicUdiDi>B-M7490081971</basicUdiDi>
    <tradeName>nDNA lgG Fluorescent Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8197</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:22:44.602Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7490081961</udiDi>
    <basicUdiDi>B-M7490081961</basicUdiDi>
    <tradeName>nDNA lgG Fluorescent Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8196</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:22:44.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>M74903200G1</udiDi>
    <basicUdiDi>B-M74903200G1</basicUdiDi>
    <tradeName>nDNA lgG Fluorescent Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3200G</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:22:37.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>M74903040G1</udiDi>
    <basicUdiDi>B-M74903040G1</basicUdiDi>
    <tradeName>nDNA lgG Fluorescent Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3040G</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:22:37.573Z</lastUpdated>
  </row>
  <row>
    <udiDi>M74903000G1</udiDi>
    <basicUdiDi>B-M74903000G1</basicUdiDi>
    <tradeName>nDNA lgG Fluorescent Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000G</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:22:37.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>M74903005G1</udiDi>
    <basicUdiDi>B-M74903005G1</basicUdiDi>
    <tradeName>nDNA lgG Fluorescent Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3005G</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:22:37.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7493002G1</udiDi>
    <basicUdiDi>B-M7493002G1</basicUdiDi>
    <tradeName>nDNA lgG Fluorescent Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3002G</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:22:36.574Z</lastUpdated>
  </row>
  <row>
    <udiDi>M74903001G1</udiDi>
    <basicUdiDi>B-M74903001G1</basicUdiDi>
    <tradeName>nDNA lgG Fluorescent Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3001G</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:22:35.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7493075G11</udiDi>
    <basicUdiDi>B-M7493075G11</basicUdiDi>
    <tradeName>nDNA lgG Fluorescent Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3075G (1)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:22:18.216Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7497096171</udiDi>
    <basicUdiDi>B-M7497096171</basicUdiDi>
    <tradeName>RELISA"' dsDNA Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7096-17</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:21:36.290Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7497096151</udiDi>
    <basicUdiDi>B-M7497096151</basicUdiDi>
    <tradeName>RELISA"' MPO ANCA Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7096-15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:21:33.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7497096161</udiDi>
    <basicUdiDi>B-M7497096161</basicUdiDi>
    <tradeName>RELISA"' PR3 ANCA Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7096-16</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:21:32.969Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7490083161</udiDi>
    <basicUdiDi>B-M7490083161</basicUdiDi>
    <tradeName>RELISA® Cardiolipin lgG/lgM Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8316</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:21:31.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7490081921</udiDi>
    <basicUdiDi>B-M7490081921</basicUdiDi>
    <tradeName>RELISA® Cardiolipin lgG/lgM Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8192</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:21:14.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7490082881</udiDi>
    <basicUdiDi>B-M7490082881</basicUdiDi>
    <tradeName>RELISA® Cardiolipin lgG/lgM Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8288</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:21:13.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7497696021</udiDi>
    <basicUdiDi>B-M7497696021</basicUdiDi>
    <tradeName>RELISA® Cardiolipin lgG/lgM Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7696-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:21:02.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7497096021</udiDi>
    <basicUdiDi>B-M7497096021</basicUdiDi>
    <tradeName>RELISA® Cardiolipin lgG/lgM Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7096-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:21:00.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>M749120210111</udiDi>
    <basicUdiDi>B-M749120210111</basicUdiDi>
    <tradeName>HISTOFLUOR"' Anti-Endomysial Autoantibody (EmA) Fluorescent Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12021-01 (1)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:20:47.705Z</lastUpdated>
  </row>
  <row>
    <udiDi>M749120090111</udiDi>
    <basicUdiDi>B-M749120090111</basicUdiDi>
    <tradeName>HISTOFLUOR"' Anti-Endomysial Autoantibody (EmA) Fluorescent Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12009-01 (1)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:20:46.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>M74912009101</udiDi>
    <basicUdiDi>B-M74912009101</basicUdiDi>
    <tradeName>HISTOFLUOR") IgG Anti-Skin Autoantibody (ASA) Fluorescent Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12009-10 (1)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:20:45.799Z</lastUpdated>
  </row>
</eudamedExport>