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<eudamedExport entity="devices">
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    <udiDi>D-GCMP(IgM)-302aVL</udiDi>
    <basicUdiDi>B-GCMP(IgM)-302aVL</basicUdiDi>
    <tradeName>M. pneumonia IgM Rapid Test Cassette (Serum/Plasma)</tradeName>
    <deviceName>M. pneumonia IgM Rapid Test Cassette (Serum/Plasma)</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCMP(IgM)-302a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:29:46.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCMP(IgM)-302aHGWR</udiDi>
    <basicUdiDi>B-GCMP(IgM)-302aHGWR</basicUdiDi>
    <tradeName>M. pneumonia IgM Rapid Test Cassette (Serum/Plasma)</tradeName>
    <deviceName>M. pneumonia IgM Rapid Test Cassette (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>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCMP(IgM)-302a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:29:45.942Z</lastUpdated>
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  <row>
    <udiDi>38594036044020</udiDi>
    <basicUdiDi>B-38594036044020</basicUdiDi>
    <tradeName>MONO-VIDITEST anti-Mycoplasma pneumoniae IgA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KZ-402-12</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:54:58.242Z</lastUpdated>
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  <row>
    <udiDi>38594036044013</udiDi>
    <basicUdiDi>B-38594036044013</basicUdiDi>
    <tradeName>MONO-VIDITEST anti-Mycoplasma pneumoniae IgM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KZ-401-12</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:54:38.944Z</lastUpdated>
  </row>
  <row>
    <udiDi>38594036044006</udiDi>
    <basicUdiDi>B-38594036044006</basicUdiDi>
    <tradeName>MONO-VIDITEST anti-Mycoplasma pneumoniae IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KZ-400-12</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:54:38.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>28594036040124</udiDi>
    <basicUdiDi>B-28594036040124</basicUdiDi>
    <tradeName>ELISA-VIDITEST anti-Mycoplasma pneumoniae IgA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ODZ-012</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:20:53.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>28594036040117</udiDi>
    <basicUdiDi>B-28594036040117</basicUdiDi>
    <tradeName>ELISA-VIDITEST anti-Mycoplasma pneumoniae IgM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ODZ-011</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:20:52.728Z</lastUpdated>
  </row>
  <row>
    <udiDi>28594036040100</udiDi>
    <basicUdiDi>B-28594036040100</basicUdiDi>
    <tradeName>ELISA-VIDITEST anti-Mycoplasma pneumoniae IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ODZ-010</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:20:51.924Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912719199</udiDi>
    <basicUdiDi>692591270093HJ</basicUdiDi>
    <tradeName>iFlash-Mycoplasma pn. IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88003G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:48:12.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912719205</udiDi>
    <basicUdiDi>692591270094HL</basicUdiDi>
    <tradeName>iFlash-Mycoplasma pn. IgM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88004M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:48:12.869Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912723752</udiDi>
    <basicUdiDi>692591270093HJ</basicUdiDi>
    <tradeName>iFlash-Mycoplasma pn. IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88003G-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:38:13.615Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912723769</udiDi>
    <basicUdiDi>692591270094HL</basicUdiDi>
    <tradeName>iFlash-Mycoplasma pn. IgM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C88004M-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:38:13.594Z</lastUpdated>
  </row>
  <row>
    <udiDi>18594036044026</udiDi>
    <basicUdiDi>B-18594036044026</basicUdiDi>
    <tradeName>MONO-VIDITEST anti-Mycoplasma pneumoniae IgA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-402-12</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:26:00.989Z</lastUpdated>
  </row>
  <row>
    <udiDi>18594036044019</udiDi>
    <basicUdiDi>B-18594036044019</basicUdiDi>
    <tradeName>MONO-VIDITEST anti-Mycoplasma pneumoniae IgM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-401-12</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:25:56.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>18594036044002</udiDi>
    <basicUdiDi>B-18594036044002</basicUdiDi>
    <tradeName>MONO-VIDITEST anti-Mycoplasma pneumoniae IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-400-12</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:25:56.183Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972698601412</udiDi>
    <basicUdiDi>B-16972698601412</basicUdiDi>
    <tradeName>Mycoplasma pneumoniae IgG/IgM Rapid Test</tradeName>
    <deviceName>Mycoplasma pneumoniae IgG/IgM Rapid Test</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P231110</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:52:25.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972698601405</udiDi>
    <basicUdiDi>B-16972698601405</basicUdiDi>
    <tradeName>Calprotectin Rapid Test</tradeName>
    <deviceName>Calprotectin Rapid Test</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P221105</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:52:21.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548250773</udiDi>
    <basicUdiDi>B-08683548250773</basicUdiDi>
    <tradeName>RapidFor™ Mycoplasma pneumoniae Ab Rapid Test Kit</tradeName>
    <deviceName>Mycoplasma pneumoniae 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>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMD65</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:10:34.727Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594036041394</udiDi>
    <basicUdiDi>B-08594036041394</basicUdiDi>
    <tradeName>ELISA-VIDITEST anti-Mycoplasma pneumoniae IgA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OD-139</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:43:16.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594036041387</udiDi>
    <basicUdiDi>B-08594036041387</basicUdiDi>
    <tradeName>ELISA-VIDITEST anti-Mycoplasma pneumoniae IgM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OD-138</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:43:15.328Z</lastUpdated>
  </row>
</eudamedExport>