<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-IM4403040HH</udiDi>
    <basicUdiDi>B-IM4403040HH</basicUdiDi>
    <tradeName>D-IM4403040HH</tradeName>
    <deviceName>Mycoplasma Pneumoniae IgG Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010899</emdnCode>
    <emdnDescription>MYCOPLASMA / UREAPLASMA  REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4403040</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:19:19.682Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4402041HC</udiDi>
    <basicUdiDi>B-IM4402041HC</basicUdiDi>
    <tradeName>D-IM4402041HC</tradeName>
    <deviceName>Mycoplasma Pneumoniae IgM Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010899</emdnCode>
    <emdnDescription>MYCOPLASMA / UREAPLASMA  REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4402041</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:17:10.768Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4402040HA</udiDi>
    <basicUdiDi>B-IM4402040HA</basicUdiDi>
    <tradeName>D-IM4402040HA</tradeName>
    <deviceName>Mycoplasma Pneumoniae IgG Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010899</emdnCode>
    <emdnDescription>MYCOPLASMA / UREAPLASMA  REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4402040</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:16:53.814Z</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-GKPD103X4</udiDi>
    <basicUdiDi>B-GKPD103X4</basicUdiDi>
    <tradeName>Mycoplasma pneumoniae IgG/IgM Ab Rapid Test Kit</tradeName>
    <deviceName>Mycoplasma pneumoniae 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>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD103</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:36:51.726Z</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-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>
  </row>
  <row>
    <udiDi>D-81649002AMP01FRDV</udiDi>
    <basicUdiDi>B-81649002AMP01FRDV</basicUdiDi>
    <tradeName>D-81649002AMP01FRDV</tradeName>
    <deviceName>Mycoplasma Pneumoniae Detection Kit (Fluorescence PCR)</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>W010501080303</emdnCode>
    <emdnDescription>UREAPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMP01-AHG48E; AMP01-AHG96E; AMP01D-AHG48E; AMP01D-AHG96E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:04:18.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-81649002AMP01DCWHF</udiDi>
    <basicUdiDi>B-81649002AMP01DCWHF</basicUdiDi>
    <tradeName>D-81649002AMP01DCWHF</tradeName>
    <deviceName>Mycoplasma Pneumoniae Fluorescence PCR Kit (Lyophilized)</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>W010501080303</emdnCode>
    <emdnDescription>UREAPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMP01D-AHG48E; AMP01D-AHG96E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:04:16.791Z</lastUpdated>
  </row>
  <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>
  </row>
  <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>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>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>
</eudamedExport>