<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-IMP-502UQ</udiDi>
    <basicUdiDi>B-IMP-502UQ</basicUdiDi>
    <tradeName>Mycoplasma pneumoniae Antigen Rapid Test Cassette</tradeName>
    <deviceName>Mycoplasma pneumoniae 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>W0105010801</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMP-502</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:36:59.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697994388Nc036ZUEJ</udiDi>
    <basicUdiDi>B-697994388Nc036ZUEJ</basicUdiDi>
    <tradeName>D-697994388Nc036ZUEJ</tradeName>
    <deviceName>Mycoplasma pneumoniae Nucleic Acid Detection Kit</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010801</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Nc036</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:27:55.128Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840313390</udiDi>
    <basicUdiDi>B-69743840313390</basicUdiDi>
    <tradeName>Mycoplasma Antigen Rapid Test</tradeName>
    <deviceName>Mycoplasma 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>W0105010801</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3022202</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:13:26.953Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IMP-R502JB</udiDi>
    <basicUdiDi>B-IMP-R502JB</basicUdiDi>
    <tradeName>Mycoplasma pneumoniae Antigen  Rapid Test Cassette</tradeName>
    <deviceName>Mycoplasma pneumoniae Antigen  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>W0105010801</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMP-R502</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:38:45.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD150XD</udiDi>
    <basicUdiDi>B-GKPD150XD</basicUdiDi>
    <tradeName>Mycoplasma pneumoniae Ab Detection Kit (Immunofluorescence Chromatography)</tradeName>
    <deviceName>Mycoplasma pneumoniae Ab Detection Kit (Immunofluorescence Chromatography)</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>W0105010801</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD150</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:38:35.111Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCMP-502aHGSP</udiDi>
    <basicUdiDi>B-GCMP-502aHGSP</basicUdiDi>
    <tradeName>M. pneumoniae Ag Rapid Test Cassette (Swab)</tradeName>
    <deviceName>M. pneumoniae 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>W0105010801</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCMP-502a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:29:50.817Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCMP-502a3U</udiDi>
    <basicUdiDi>B-GCMP-502a3U</basicUdiDi>
    <tradeName>M. pneumoniae Ag Rapid Test Cassette (Swab)</tradeName>
    <deviceName>M. pneumoniae 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>W0105010801</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCMP-502a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:29:46.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1O26C5YS</udiDi>
    <basicUdiDi>B-1O26C5YS</basicUdiDi>
    <tradeName>Rapid Mycoplasma Pneumoniae Antigen Test</tradeName>
    <deviceName>Rapid Mycoplasma Pneumoniae Antigen Test</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010801</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1O26C5-1-EU,1O26C5-20-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:17:49.444Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684595030431</udiDi>
    <basicUdiDi>B-08684595030431</basicUdiDi>
    <tradeName>RapidFor™ ADV + M. pneumoniae Combo Rapid Test Kit</tradeName>
    <deviceName>ADV + M. pneumoniae Combo 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>W0105010801</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMD101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:13:53.977Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684595030370</udiDi>
    <basicUdiDi>B-08684595030370</basicUdiDi>
    <tradeName>RapidFor™ Mycoplasma pneumoniae Ag Rapid Test Kit</tradeName>
    <deviceName>Mycoplasma pneumoniae Ag 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>W0105010801</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMD82</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:13:46.773Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684595030035</udiDi>
    <basicUdiDi>B-08684595030035</basicUdiDi>
    <tradeName>RapidFor™ Mycoplasma pneumonia (FIA)</tradeName>
    <deviceName>Mycoplasma pneumonia (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010801</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMPO63</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:12:44.270Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977903344613</udiDi>
    <basicUdiDi>B-06977903344613</basicUdiDi>
    <tradeName>06977903344613</tradeName>
    <deviceName>Mycoplasma Pneumoniae Antigen Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010801</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110122C01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:33:58.505Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977903344620</udiDi>
    <basicUdiDi>B-06977903344620</basicUdiDi>
    <tradeName>06977903344620</tradeName>
    <deviceName>Mycoplasma Pneumoniae Antigen Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010801</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110122C25</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:33:57.697Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977698402345</udiDi>
    <basicUdiDi>B-06977698402345</basicUdiDi>
    <tradeName>DOA Rapid Urine Test Device Strip/Cassette/Panel(Colloidal Gold )</tradeName>
    <deviceName>DOA Rapid Urine Test Device Strip/Cassette/Panel(Colloidal Gold )</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010801</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD043</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:28:35.560Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977698401416</udiDi>
    <basicUdiDi>B-06977698401416</basicUdiDi>
    <tradeName>TB IgG/lgM Rapid Test Cassette (Colloidal Gold)</tradeName>
    <deviceName>TB IgG/lgM Rapid Test Cassette (Colloidal Gold)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010801</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD031</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:28:16.354Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971792053182</udiDi>
    <basicUdiDi>B-06971792053182</basicUdiDi>
    <tradeName>M.Pneumonia Antigen Rapid Test Device</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Realy Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004716</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010801</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K681416D</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:56:26.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804827120</udiDi>
    <basicUdiDi>B-06952804827120</basicUdiDi>
    <tradeName>Mycoplasma pneumoniae Antigen Rapid Test</tradeName>
    <deviceName>Mycoplasma pneumoniae Antigen Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010801</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MP-S23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:32:43.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260207985</udiDi>
    <basicUdiDi>B-06933260207985</basicUdiDi>
    <tradeName>Mycoplasma Pneumoniae Antigen Rapid Qualitative Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010801</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0102601</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:59:03.976Z</lastUpdated>
  </row>
</eudamedExport>