<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>M7492040RO1</udiDi>
    <basicUdiDi>B-M7492040RO1</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>2040-Ro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:30:00.515Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7494075RO11</udiDi>
    <basicUdiDi>B-M7494075RO11</basicUdiDi>
    <tradeName>ANA-Ro (Hep-2000®) Colorzyme® 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>4075-Ro (1)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:29:59.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>M74981551RO1</udiDi>
    <basicUdiDi>B-M74981551RO1</basicUdiDi>
    <tradeName>ANA-Ro (Hep-2000®) Colorzyme® 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>8155.1-Ro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:29:50.607Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7494000RO1</udiDi>
    <basicUdiDi>B-M7494000RO1</basicUdiDi>
    <tradeName>ANA-Ro (Hep-2000®) Colorzyme® 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>4000-Ro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:29:48.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>M749400014RO1</udiDi>
    <basicUdiDi>B-M749400014RO1</basicUdiDi>
    <tradeName>ANA-Ro (Hep-2000®) Colorzyme® 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>4000-14-Ro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:29:36.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>M749400018RO1</udiDi>
    <basicUdiDi>B-M749400018RO1</basicUdiDi>
    <tradeName>ANA-Ro (Hep-2000®) Colorzyme® 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>4000-18-Ro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:26:16.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7494200RO1</udiDi>
    <basicUdiDi>B-M7494200RO1</basicUdiDi>
    <tradeName>ANA-Ro (Hep-2000®) Colorzyme® 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>4200-Ro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:26:00.975Z</lastUpdated>
  </row>
  <row>
    <udiDi>M749420014RO1</udiDi>
    <basicUdiDi>B-M749420014RO1</basicUdiDi>
    <tradeName>ANA-Ro (Hep-2000®) Colorzyme® 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>4200-14-Ro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:25:46.223Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7494040RO1</udiDi>
    <basicUdiDi>B-M7494040RO1</basicUdiDi>
    <tradeName>ANA-Ro (Hep-2000®) Colorzyme® 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>4040-Ro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:24:07.269Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7490110541</udiDi>
    <basicUdiDi>B-M7490110541</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>1105 (4)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:24:06.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7492075GRO11</udiDi>
    <basicUdiDi>B-M7492075GRO11</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>2075G-Ro (1)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:23:54.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7492075GCSRO11</udiDi>
    <basicUdiDi>B-M7492075GCSRO11</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>2075GCS-Ro (1)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:23:34.179Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7498198RO1</udiDi>
    <basicUdiDi>B-M7498198RO1</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>8198-Ro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:23:16.572Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7498206RO1</udiDi>
    <basicUdiDi>B-M7498206RO1</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>8206-Ro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:23:15.039Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7498279RO1</udiDi>
    <basicUdiDi>B-M7498279RO1</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>8279-Ro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:23:11.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7498252RO1</udiDi>
    <basicUdiDi>B-M7498252RO1</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>8252-Ro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:23:03.623Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7498226RO1</udiDi>
    <basicUdiDi>B-M7498226RO1</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>8226-Ro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:23:01.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7498247RO1</udiDi>
    <basicUdiDi>B-M7498247RO1</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>8247-Ro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:22:47.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7498232RO1</udiDi>
    <basicUdiDi>B-M7498232RO1</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>8232-Ro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:22:35.873Z</lastUpdated>
  </row>
  <row>
    <udiDi>M7498209RO1</udiDi>
    <basicUdiDi>B-M7498209RO1</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>8209-Ro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:22:29.165Z</lastUpdated>
  </row>
</eudamedExport>