<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-GCCOV-502a-H1OGEEP</udiDi>
    <basicUdiDi>B-GCCOV-502a-H1OGEEP</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-H1OGE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:24:28.653Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV-502a-H18B</udiDi>
    <basicUdiDi>B-GCCOV-502a-H18B</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-H1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:24:27.768Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV-502a-H15OGETY</udiDi>
    <basicUdiDi>B-GCCOV-502a-H15OGETY</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-H15OGE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:24:23.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV-502a-H15GQ</udiDi>
    <basicUdiDi>B-GCCOV-502a-H15GQ</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-H15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:24:22.254Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV-502a-H10OGESV</udiDi>
    <basicUdiDi>B-GCCOV-502a-H10OGESV</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-H10OGE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:24:21.247Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV-502a-H10GE</udiDi>
    <basicUdiDi>B-GCCOV-502a-H10GE</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-H10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:24:17.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440205999</udiDi>
    <basicUdiDi>84354402IDXGASTROB_RT8H</basicUdiDi>
    <tradeName>CerTest Rotavirus+Adenovirus+Astrovirus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RT872001VC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:59:12.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440207641</udiDi>
    <basicUdiDi>84354402IDXGASTROB_RT8H</basicUdiDi>
    <tradeName>CerTest Rotavirus+Adenovirus+Astrovirus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RT872001VCC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:59:12.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440206057</udiDi>
    <basicUdiDi>84354402IDXGASTROB_XR8X</basicUdiDi>
    <tradeName>CerTest Rotavirus+Adenovirus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XR882001VC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:59:11.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440207740</udiDi>
    <basicUdiDi>84354402IDXGASTROB_XR8X</basicUdiDi>
    <tradeName>CerTest Rotavirus+Adenovirus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XR882001VCC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:58:56.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440201458</udiDi>
    <basicUdiDi>84354402IDXGASTROB_AT6W</basicUdiDi>
    <tradeName>CerTest Astrovirus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AT820001VC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:41.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440207344</udiDi>
    <basicUdiDi>84354402IDXGASTROB_AT6W</basicUdiDi>
    <tradeName>CerTest Astrovirus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AT820001VCC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:40.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIMF16823COV7S67</udiDi>
    <basicUdiDi>B-FIMF16823COV7S67</basicUdiDi>
    <tradeName>D-FIMF16823COV7S67</tradeName>
    <deviceName>Salocor SARS-CoV-2 Antigen Rapid Test Cassette (Nasal Swab)</deviceName>
    <manufacturerName>Salofa Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000016823</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COV-07-S</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:32:25.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIMF16823COV06SEQ</udiDi>
    <basicUdiDi>B-FIMF16823COV06SEQ</basicUdiDi>
    <tradeName>D-FIMF16823COV06SEQ</tradeName>
    <deviceName>Salocor SARS-CoV-2 Antigen Rapid Test Cassette (Nasopharyngeal Swab)</deviceName>
    <manufacturerName>Salofa Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000016823</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COV-06-S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:32:24.805Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIMF16823COV062STG</udiDi>
    <basicUdiDi>B-FIMF16823COV062STG</basicUdiDi>
    <tradeName>D-FIMF16823COV062STG</tradeName>
    <deviceName>Salocor SARS-CoV-2 Antigen Rapid Test Cassette (Saliva / Nasopharyngeal Swab)</deviceName>
    <manufacturerName>Salofa Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000016823</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COV-062-S</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:32:20.832Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIMF16823COV061STD</udiDi>
    <basicUdiDi>B-FIMF16823COV061STD</basicUdiDi>
    <tradeName>D-FIMF16823COV061STD</tradeName>
    <deviceName>Salocor SARS-CoV-2 Antigen Rapid Test Cassette (Saliva)</deviceName>
    <manufacturerName>Salofa Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000016823</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COV-061-S</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:32:20.004Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIMF16823CLACOV19AGVIAB</udiDi>
    <basicUdiDi>B-FIMF16823CLACOV19AGVIAB</basicUdiDi>
    <tradeName>D-FIMF16823CLACOV19AGVIAB</tradeName>
    <deviceName>Clarity COVID-19 Antigen Rapid Test Cassette</deviceName>
    <manufacturerName>Salofa Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000016823</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLA-COV19AG-VIS</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:32:19.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIMF16823102261KZ</udiDi>
    <basicUdiDi>B-FIMF16823102261KZ</basicUdiDi>
    <tradeName>D-FIMF16823102261KZ</tradeName>
    <deviceName>Sienna COVID-19 Antigen Rapid Test Cassette (Saliva / Nasopharyngeal Swab)</deviceName>
    <manufacturerName>Salofa Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000016823</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102261</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:32:11.995Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIMF16823102251KW</udiDi>
    <basicUdiDi>B-FIMF16823102251KW</basicUdiDi>
    <tradeName>D-FIMF16823102251KW</tradeName>
    <deviceName>Sienna COVID-19 Antigen Rapid Test Cassette (Saliva)</deviceName>
    <manufacturerName>Salofa Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000016823</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102251</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:32:07.998Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIMF1682310224XN7</udiDi>
    <basicUdiDi>B-FIMF1682310224XN7</basicUdiDi>
    <tradeName>D-FIMF1682310224XN7</tradeName>
    <deviceName>Sienna COVID-19 Antigen Rapid Test Cassette (Nasopharyngeal Swab)</deviceName>
    <manufacturerName>Salofa Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000016823</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10224X</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:32:07.188Z</lastUpdated>
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</eudamedExport>