<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06933260212460</udiDi>
    <basicUdiDi>B-06933260212460</basicUdiDi>
    <tradeName>Novel Coronavirus (SARSCoV-2) Real Time Multiplex RT-PCR Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:56:36.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944760250020</udiDi>
    <basicUdiDi>594476025TESTERAPIDEUY</basicUdiDi>
    <tradeName>ROTAVIRUS RAPID TEST CASSETTE (FECES)</tradeName>
    <deviceName>RAPID TEST CASSETTE</deviceName>
    <manufacturerName>Tody Laboratories Int. SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000032726</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040606</emdnCode>
    <emdnDescription>ROTAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C61RT1005</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:27:35.616Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026626167</udiDi>
    <basicUdiDi>357302BUDI000921TX</basicUdiDi>
    <tradeName>VIDAS® Anti-CHIKUNGUNYA IgG</tradeName>
    <deviceName>VIDAS® Anti-CHIKUNGUNYA IgG</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040625</emdnCode>
    <emdnDescription>CHIKUNGUNYA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>423230-30</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:04:51.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026626150</udiDi>
    <basicUdiDi>357302BUDI000920TV</basicUdiDi>
    <tradeName>VIDAS® Anti-CHIKUNGUNYA IgM</tradeName>
    <deviceName>VIDAS® Anti-CHIKUNGUNYA IgM</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040625</emdnCode>
    <emdnDescription>CHIKUNGUNYA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>423229-30</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:04:50.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026610357</udiDi>
    <basicUdiDi>357302BUDI000921TX</basicUdiDi>
    <tradeName>VIDAS® Anti-CHIKUNGUNYA IgG</tradeName>
    <deviceName>VIDAS® Anti-CHIKUNGUNYA IgG</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040625</emdnCode>
    <emdnDescription>CHIKUNGUNYA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>423230</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:58:02.522Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026610340</udiDi>
    <basicUdiDi>357302BUDI000920TV</basicUdiDi>
    <tradeName>VIDAS® Anti-CHIKUNGUNYA IgM</tradeName>
    <deviceName>VIDAS® Anti-CHIKUNGUNYA IgM</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040625</emdnCode>
    <emdnDescription>CHIKUNGUNYA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>423229</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:58:01.733Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026608217</udiDi>
    <basicUdiDi>357302BUDI000852U5</basicUdiDi>
    <tradeName>VIDAS® DENGUE NS1 Ag</tradeName>
    <deviceName>VIDAS® DENGUE NS1 Ag</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>423077</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:57:56.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IAS-R602DB</udiDi>
    <basicUdiDi>B-IAS-R602DB</basicUdiDi>
    <tradeName>Astrovirus Rapid Test Cassette</tradeName>
    <deviceName>Astrovirus Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040629</emdnCode>
    <emdnDescription>ASTROVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IAS-R602</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:09:11.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060147182946</udiDi>
    <basicUdiDi>B-86060147182946</basicUdiDi>
    <tradeName>Adenovirus IgM</tradeName>
    <deviceName>Adenovirus IgM</deviceName>
    <manufacturerName>NEOMEDICA DOO NIŠ</manufacturerName>
    <manufacturerSrn>RS-MF-000021305</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040601</emdnCode>
    <emdnDescription>ADENOVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N102V24IGM</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T23:29:44.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060147182878</udiDi>
    <basicUdiDi>B-86060147182878</basicUdiDi>
    <tradeName>Adenovirus IgG</tradeName>
    <deviceName>Adenovirus IgG</deviceName>
    <manufacturerName>NEOMEDICA DOO NIŠ</manufacturerName>
    <manufacturerSrn>RS-MF-000021305</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040601</emdnCode>
    <emdnDescription>ADENOVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N101V24IGG</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T23:29:44.070Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FI-FLU-502TY</udiDi>
    <basicUdiDi>B-FI-FLU-502TY</basicUdiDi>
    <tradeName>Influenza A+B Test Cassette</tradeName>
    <deviceName>Influenza A+B Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040604</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FI-FLU-502</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-28T03:47:13.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056771104043</udiDi>
    <basicUdiDi>80567713115604G</basicUdiDi>
    <tradeName>LIAISON® Biotrin Parvovirus B19 IgM Plus</tradeName>
    <deviceName>LIAISON® Biotrin Parvovirus B19 IgM Plus</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040609</emdnCode>
    <emdnDescription>PARVOVIRUS B 19</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>311560</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-28T00:40:09.834Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IFA-502LQ</udiDi>
    <basicUdiDi>B-IFA-502LQ</basicUdiDi>
    <tradeName>H1N1 Antigen Rapid Test Cassette</tradeName>
    <deviceName>H1N1 Antigen Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040604</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFA-502</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-27T22:05:34.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IFA-501LN</udiDi>
    <basicUdiDi>B-IFA-501LN</basicUdiDi>
    <tradeName>H1N1 Antigen Rapid Test Dipstick</tradeName>
    <deviceName>H1N1 Antigen Rapid Test Dipstick</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040604</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFA-501</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-27T22:05:33.230Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IAD-502KQ</udiDi>
    <basicUdiDi>B-IAD-502KQ</basicUdiDi>
    <tradeName>Adenovirus Antigen Rapid Test Cassette (Swab)</tradeName>
    <deviceName>Adenovirus Antigen Rapid Test Cassette (Swab)</deviceName>
    <manufacturerName>Acro Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017832</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040601</emdnCode>
    <emdnDescription>ADENOVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IAD-502</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T22:05:26.812Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974238911213</udiDi>
    <basicUdiDi>B-06974238911213</basicUdiDi>
    <tradeName>Ebola Virus Nucleic Acid Detection Kit</tradeName>
    <deviceName>Ebola Virus Nucleic Acid Detection Kit (Lyophilized Fluorescent PCR Method)</deviceName>
    <manufacturerName>Hangzhou Immuno Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001118</manufacturerSrn>
    <authorisedRepresentativeName>Immuno International BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000043887</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040627</emdnCode>
    <emdnDescription>EBOLA (FILOVIRUS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PEB001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-26T08:08:24.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056771104005</udiDi>
    <basicUdiDi>80567713115404A</basicUdiDi>
    <tradeName>LIAISON® Biotrin Parvovirus B19 IgG Plus</tradeName>
    <deviceName>LIAISON® Biotrin Parvovirus B19 IgG Plus</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040609</emdnCode>
    <emdnDescription>PARVOVIRUS B 19</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>311540</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-22T22:39:46.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056771101165</udiDi>
    <basicUdiDi>B-08056771101165</basicUdiDi>
    <tradeName>LIAISON® Biotrin Parvovirus B19 IgM</tradeName>
    <deviceName>LIAISON® Biotrin Parvovirus B19 IgM</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040609</emdnCode>
    <emdnDescription>PARVOVIRUS B 19</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>317010</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-22T22:39:31.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IZIG-402NX</udiDi>
    <basicUdiDi>B-IZIG-402NX</basicUdiDi>
    <tradeName>Zika NS1 Rapid Test Cassette</tradeName>
    <deviceName>Zika NS1 Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IZIG-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:49:58.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IZIC-425MX</udiDi>
    <basicUdiDi>B-IZIC-425MX</basicUdiDi>
    <tradeName>Zika IgG/IgM and NS1 Combo Rapid Test Cassette</tradeName>
    <deviceName>Zika IgG/IgM and NS1 Combo Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IZIC-425</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-22T21:49:57.924Z</lastUpdated>
  </row>
</eudamedExport>