<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>69743840309812</udiDi>
    <basicUdiDi>B-69743840309812</basicUdiDi>
    <tradeName>Monkeypox Antigen Rapid Test</tradeName>
    <deviceName>Monkeypox Antigen Rapid Test</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099008</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3027101</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:11:49.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840309508</udiDi>
    <basicUdiDi>B-69743840309508</basicUdiDi>
    <tradeName>Monkeypox Antibody Rapid Test (Whole blood/Serum/Plasma)</tradeName>
    <deviceName>Monkeypox Antibody Rapid Test (Whole blood/Serum/Plasma)</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099008</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3027102</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:11:45.417Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646MON005N54C</udiDi>
    <basicUdiDi>B-697424646MON005N54C</basicUdiDi>
    <tradeName>Monkeypox Virus Antigen Rapid Test(Swab)</tradeName>
    <deviceName>Monkeypox Virus Antigen Rapid Test(Swab)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000051497</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099008</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MON Ag-6012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:09:26.836Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646MON004N343</udiDi>
    <basicUdiDi>B-697424646MON004N343</basicUdiDi>
    <tradeName>Monkeypox Virus Antigen Rapid Test(Serum/Plasma)</tradeName>
    <deviceName>Monkeypox Virus Antigen Rapid Test(Serum/Plasma)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000051497</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099008</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MON Ag-3012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:09:25.890Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646MON003MZ67</udiDi>
    <basicUdiDi>B-697424646MON003MZ67</basicUdiDi>
    <tradeName>Monkeypox Virus Antigen Rapid Test(Whole blood/Serum/Plasma)</tradeName>
    <deviceName>Monkeypox Virus Antigen Rapid Test(Whole blood/Serum/Plasma)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000051497</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099008</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MON Ag-4012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:09:25.782Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646MON002MX5W</udiDi>
    <basicUdiDi>B-697424646MON002MX5W</basicUdiDi>
    <tradeName>Monkeypox Virus IgG/IgM  Rapid Test(Serum/Plasma)</tradeName>
    <deviceName>Monkeypox Virus IgG/IgM  Rapid Test(Serum/Plasma)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000051497</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099008</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MON Ab-3022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:09:25.737Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646MON001MV5M</udiDi>
    <basicUdiDi>B-697424646MON001MV5M</basicUdiDi>
    <tradeName>Monkeypox Virus IgG/IgM  Rapid Test(Whole blood/Serum/Plasma)</tradeName>
    <deviceName>Monkeypox Virus IgG/IgM  Rapid Test(Whole blood/Serum/Plasma)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000051497</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099008</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MON Ab-4022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:09:21.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646MON000MT5C</udiDi>
    <basicUdiDi>B-697424646MON000MT5C</basicUdiDi>
    <tradeName>Monkeypox Virus Antigen Rapid Test</tradeName>
    <deviceName>Monkeypox Virus Antigen Rapid Test</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099008</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MON Ag-4012/MON Ag-3012/MON Ag-6012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:09:18.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976232252163</udiDi>
    <basicUdiDi>B-06976232252163</basicUdiDi>
    <tradeName>Acmex</tradeName>
    <deviceName>Monkeypox Virus (MPXV) Antigen Rapid Test</deviceName>
    <manufacturerName>Acmex Bio-Technology (Chongqing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037745</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099008</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA03-70-422P25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:32:42.868Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IMXG-R402HE</udiDi>
    <basicUdiDi>B-IMXG-R402HE</basicUdiDi>
    <tradeName>Monkeypox Virus Antigen Rapid Test</tradeName>
    <deviceName>Monkeypox Virus Antigen Rapid Test</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>W0105099008</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMXG-R402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:39:17.455Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IMXB-R402FD</udiDi>
    <basicUdiDi>B-IMXB-R402FD</basicUdiDi>
    <tradeName>Monkeypox Virus Antibody Rapid Test</tradeName>
    <deviceName>Monkeypox Virus Antibody Rapid Test</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>W0105099008</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMXB-R402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:39:13.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD124XC</udiDi>
    <basicUdiDi>B-GKPD124XC</basicUdiDi>
    <tradeName>Mpox Virus IgG/IgM Ab Rapid Test Kit</tradeName>
    <deviceName>Mpox Virus IgG/IgM Ab Rapid Test Kit</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099008</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD124</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:37:39.850Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD123XA</udiDi>
    <basicUdiDi>B-GKPD123XA</basicUdiDi>
    <tradeName>Mpox Virus Ag Rapid Test Kit</tradeName>
    <deviceName>Mpox Virus Ag Rapid Test Kit</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099008</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD123</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:37:39.027Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCMKP-502bHG79</udiDi>
    <basicUdiDi>B-GCMKP-502bHG79</basicUdiDi>
    <tradeName>Monkeypox Ag Rapid Test Cassette (Swab)</tradeName>
    <deviceName>Monkeypox Ag 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>W0105099008</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCMKP-502b</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:29:33.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCMKP-502b5Q</udiDi>
    <basicUdiDi>B-GCMKP-502b5Q</basicUdiDi>
    <tradeName>Monkeypox Ag Rapid Test Cassette (Swab)</tradeName>
    <deviceName>Monkeypox Ag 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>W0105099008</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCMKP-502b</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:29:32.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCMKP-402aHG6P</udiDi>
    <basicUdiDi>B-GCMKP-402aHG6P</basicUdiDi>
    <tradeName>Monkeypox IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Monkeypox IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</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>W0105099008</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCMKP-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:29:31.612Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCMKP-402a5F</udiDi>
    <basicUdiDi>B-GCMKP-402a5F</basicUdiDi>
    <tradeName>Monkeypox IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Monkeypox IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</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>W0105099008</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCMKP-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:29:27.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349CR017GL</udiDi>
    <basicUdiDi>B-CNMF000054349CR017GL</basicUdiDi>
    <tradeName>Monkeypox Virus Antigen Rapid Test Kit</tradeName>
    <deviceName>Monkeypox Virus Antigen Rapid Test Kit</deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099008</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR017</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:07:40.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349CR015GG</udiDi>
    <basicUdiDi>B-CNMF000054349CR015GG</basicUdiDi>
    <tradeName>Monkeypox Virus Antibody Rapid Test Kit</tradeName>
    <deviceName>Monkeypox Virus Antibody Rapid Test Kit</deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099008</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:07:38.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548252050</udiDi>
    <basicUdiDi>B-08683548252050</basicUdiDi>
    <tradeName>RapidFor™Monkeypox Virus Ab Rapid Test Kit</tradeName>
    <deviceName>Monkeypox Virus Ab Rapid Test Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099008</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMD74</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:13:33.406Z</lastUpdated>
  </row>
</eudamedExport>