<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-GCFR(A)-T502aMC</udiDi>
    <basicUdiDi>B-GCFR(A)-T502aMC</basicUdiDi>
    <tradeName>Flu A/RSV Ag Combo Rapid Test Cassette (Swab)</tradeName>
    <deviceName>Flu A/RSV Ag Combo Rapid Test Cassette (Swab)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCFR(A)-T502a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:27:13.133Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCFR-T502a4G</udiDi>
    <basicUdiDi>B-GCFR-T502a4G</basicUdiDi>
    <tradeName>Flu A&amp;B/RSV Ag Combo Rapid Test Cassette (Swab)</tradeName>
    <deviceName>Flu A&amp;B/RSV Ag Combo Rapid Test Cassette (Swab)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCFR-T502a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:27:09.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCFCRAMP-T535aDE</udiDi>
    <basicUdiDi>B-GCFCRAMP-T535aDE</basicUdiDi>
    <tradeName>COVID-19/Flu A/Flu B/RSV/ADV/M.P Ag Combo Rapid Test Cassette (Swab)</tradeName>
    <deviceName>COVID-19/Flu A/Flu B/RSV/ADV/M.P Ag Combo Rapid Test Cassette (Swab)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCFCRAMP-T535a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:26:42.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCFCRA-T525a8X</udiDi>
    <basicUdiDi>B-GCFCRA-T525a8X</basicUdiDi>
    <tradeName>COVID-19/Flu A&amp;B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab)</tradeName>
    <deviceName>COVID-19/Flu A&amp;B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCFCRA-T525a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:26:37.786Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCFCRA-545aWP</udiDi>
    <basicUdiDi>B-GCFCRA-545aWP</basicUdiDi>
    <tradeName>Flu, COVID-19, RSV &amp; Adeno Ag Combo Test Cassette (Swab)</tradeName>
    <deviceName>Flu, COVID-19, RSV &amp; Adeno Ag Combo Test Cassette (Swab)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCFCRA-545a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:26:35.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCFCR-T525a3T</udiDi>
    <basicUdiDi>B-GCFCR-T525a3T</basicUdiDi>
    <tradeName>COVID-19/Flu A&amp;B/RSV Ag Combo Rapid Test Cassette (Swab)</tradeName>
    <deviceName>COVID-19/Flu A&amp;B/RSV Ag Combo Rapid Test Cassette (Swab)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCFCR-T525a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:26:29.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCFCR-T525a-NNNG</udiDi>
    <basicUdiDi>B-GCFCR-T525a-NNNG</basicUdiDi>
    <tradeName>COVID-19 /Flu A&amp;B /RSV Ag Combo Rapid Test Cassette (Swab)</tradeName>
    <deviceName>COVID-19 /Flu A&amp;B /RSV Ag Combo Rapid Test Cassette (Swab)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCFCR-T525a-NN</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:26:28.136Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCFCR-T525a-NNHGR9</udiDi>
    <basicUdiDi>B-GCFCR-T525a-NNHGR9</basicUdiDi>
    <tradeName>COVID-19 /Flu A&amp;B /RSV Ag Combo Rapid Test Cassette (Swab)</tradeName>
    <deviceName>COVID-19 /Flu A&amp;B /RSV Ag Combo Rapid  Test Cassette (Swab)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCFCR-T525a-NN</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:26:24.168Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCFCR-T525Sa-DD4H</udiDi>
    <basicUdiDi>B-GCFCR-T525Sa-DD4H</basicUdiDi>
    <tradeName>COVID-19+Flu A&amp;B+RSV Ag Combo Rapid Test Cassette (Swab)</tradeName>
    <deviceName>COVID-19+Flu A&amp;B+RSV Ag Combo Rapid Test Cassette (Swab)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCFCR-T525Sa-DD</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:26:22.528Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV-502a-H8OGEG8</udiDi>
    <basicUdiDi>B-GCCOV-502a-H8OGEG8</basicUdiDi>
    <tradeName>Rapid COVID-19 (Antigen) Self-Test</tradeName>
    <deviceName>Rapid COVID-19 (Antigen) Self-Test</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV-502a-H8OGE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:24:46.254Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV-502a-H7OGEFZ</udiDi>
    <basicUdiDi>B-GCCOV-502a-H7OGEFZ</basicUdiDi>
    <tradeName>Rapid COVID-19 (Antigen) Self-Test</tradeName>
    <deviceName>Rapid COVID-19 (Antigen) Self-Test</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV-502a-H7OGE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:24:45.455Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV-502a-H78P</udiDi>
    <basicUdiDi>B-GCCOV-502a-H78P</basicUdiDi>
    <tradeName>Rapid COVID-19 Antigen Self-Test</tradeName>
    <deviceName>Rapid COVID-19 Antigen Self-Test</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV-502a-H7</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:24:42.260Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV-502a-H5OGEFK</udiDi>
    <basicUdiDi>B-GCCOV-502a-H5OGEFK</basicUdiDi>
    <tradeName>Rapid COVID-19 (Antigen) Self-Test</tradeName>
    <deviceName>Rapid COVID-19 (Antigen) Self-Test</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV-502a-H5OGE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:24:41.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV-502a-H58K</udiDi>
    <basicUdiDi>B-GCCOV-502a-H58K</basicUdiDi>
    <tradeName>Rapid COVID-19 Antigen Self-Test</tradeName>
    <deviceName>Rapid COVID-19 Antigen Self-Test</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV-502a-H5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:24:40.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV-502a-H3OGEF5</udiDi>
    <basicUdiDi>B-GCCOV-502a-H3OGEF5</basicUdiDi>
    <tradeName>Rapid COVID-19 (Antigen) Self-Test</tradeName>
    <deviceName>Rapid COVID-19 (Antigen) Self-Test</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV-502a-H3OGE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:24:37.452Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV-502a-H38F</udiDi>
    <basicUdiDi>B-GCCOV-502a-H38F</basicUdiDi>
    <tradeName>Rapid COVID-19 Antigen Self-Test</tradeName>
    <deviceName>Rapid COVID-19 Antigen Self-Test</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV-502a-H3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:24:36.658Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV-502a-H28D</udiDi>
    <basicUdiDi>B-GCCOV-502a-H28D</basicUdiDi>
    <tradeName>Rapid COVID-19 Antigen Self-Test</tradeName>
    <deviceName>Rapid COVID-19 Antigen Self-Test</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV-502a-H2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:24:35.054Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV-502a-H25OGEUB</udiDi>
    <basicUdiDi>B-GCCOV-502a-H25OGEUB</basicUdiDi>
    <tradeName>Rapid COVID-19 (Antigen) Self-Test</tradeName>
    <deviceName>Rapid COVID-19 (Antigen) Self-Test</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV-502a-H25OGE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:24:31.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV-502a-H20OGET8</udiDi>
    <basicUdiDi>B-GCCOV-502a-H20OGET8</basicUdiDi>
    <tradeName>Rapid COVID-19 (Antigen) Self-Test</tradeName>
    <deviceName>Rapid COVID-19 (Antigen) Self-Test</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV-502a-H20OGE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:24:30.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV-502a-H20GH</udiDi>
    <basicUdiDi>B-GCCOV-502a-H20GH</basicUdiDi>
    <tradeName>Rapid COVID-19 Antigen Self-Test</tradeName>
    <deviceName>Rapid COVID-19 Antigen Self-Test</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV-502a-H20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:24:29.448Z</lastUpdated>
  </row>
</eudamedExport>