<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>M7492280CSRO1</udiDi>
    <basicUdiDi>B-M7492280CSRO1</basicUdiDi>
    <tradeName>ANA-Ro (Hep-2000®) 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>2280CS-Ro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:09:39.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7492200CS14RO1</udiDi>
    <basicUdiDi>B-M7492200CS14RO1</basicUdiDi>
    <tradeName>ANA-Ro (Hep-2000®) 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>2200CS-14-Ro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:09:39.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7492288CSRO1</udiDi>
    <basicUdiDi>B-M7492288CSRO1</basicUdiDi>
    <tradeName>ANA-Ro (Hep-2000®) 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>2288CS-Ro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:09:08.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7492420CSRO1</udiDi>
    <basicUdiDi>B-M7492420CSRO1</basicUdiDi>
    <tradeName>ANA-Ro (Hep-2000®) 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>2420CS-Ro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:08:59.198Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7492004G14RO1</udiDi>
    <basicUdiDi>B-M7492004G14RO1</basicUdiDi>
    <tradeName>ANA-Ro (Hep-2000®) 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>2004G-14-Ro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:08:53.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7492000G14RO1</udiDi>
    <basicUdiDi>B-M7492000G14RO1</basicUdiDi>
    <tradeName>ANA-Ro (Hep-2000®) 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>2000G-14-Ro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:31:16.659Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7492004G21RO1</udiDi>
    <basicUdiDi>B-M7492004G21RO1</basicUdiDi>
    <tradeName>ANA-Ro (Hep-2000®) 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>2004G-21-Ro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:31:16.001Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7492000G21RO1</udiDi>
    <basicUdiDi>B-M7492000G21RO1</basicUdiDi>
    <tradeName>ANA-Ro (Hep-2000®) 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>2000G-21-Ro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:31:15.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7492140GRO1</udiDi>
    <basicUdiDi>B-M7492140GRO1</basicUdiDi>
    <tradeName>ANA-Ro (Hep-2000®) 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>2140G-Ro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:31:14.848Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7492145GRO1</udiDi>
    <basicUdiDi>B-M7492145GRO1</basicUdiDi>
    <tradeName>ANA-Ro (Hep-2000®) 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>2145G-Ro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:31:07.513Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7492200GRO1</udiDi>
    <basicUdiDi>B-M7492200GRO1</basicUdiDi>
    <tradeName>ANA-Ro (Hep-2000®) 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>2200G-Ro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:31:06.127Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7492280GRO1</udiDi>
    <basicUdiDi>B-M7492280GRO1</basicUdiDi>
    <tradeName>ANA-Ro (Hep-2000®) 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>2280G-Ro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:31:02.861Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7492200G14RO1</udiDi>
    <basicUdiDi>B-M7492200G14RO1</basicUdiDi>
    <tradeName>ANA-Ro (Hep-2000®) 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>2200G-14-Ro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:31:02.189Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7497096111</udiDi>
    <basicUdiDi>B-M7497096111</basicUdiDi>
    <tradeName>RELISA® ANA Screening 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>7096-11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:30:52.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7498400RO1</udiDi>
    <basicUdiDi>B-M7498400RO1</basicUdiDi>
    <tradeName>ANA-Ro (Hep-2000®) 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>8400-Ro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:30:49.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7497696111</udiDi>
    <basicUdiDi>B-M7497696111</basicUdiDi>
    <tradeName>RELISA® ANA Screening 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>7696-11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:30:34.282Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7497696091</udiDi>
    <basicUdiDi>B-M7497696091</basicUdiDi>
    <tradeName>RELISA® ENA Multiparameter Screening 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>7696-09</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:30:33.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7497096091</udiDi>
    <basicUdiDi>B-M7497096091</basicUdiDi>
    <tradeName>RELISA® ENA Multiparameter Screening 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>7096-09</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:30:32.450Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7497696101</udiDi>
    <basicUdiDi>B-M7497696101</basicUdiDi>
    <tradeName>RELISA® ENA Single Well Screen 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>7696-10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:30:31.216Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7497096101</udiDi>
    <basicUdiDi>B-M7497096101</basicUdiDi>
    <tradeName>RELISA® ENA Single Well Screen 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>7096-10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:30:30.371Z</lastUpdated>
  </row>
</eudamedExport>