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<eudamedExport entity="devices">
  <row>
    <udiDi>D-JB(Z)60104NW-48T65</udiDi>
    <basicUdiDi>B-JB(Z)60104NW-48T65</basicUdiDi>
    <tradeName>Mycoplasma Genitalium Real Time PCR Kit</tradeName>
    <deviceName>Mycoplasma Genitalium Real Time PCR Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010803</emdnCode>
    <emdnDescription>MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JB(Z)60104NW-48T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:22:08.720Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-JB(Z)60104NW-24T5F</udiDi>
    <basicUdiDi>B-JB(Z)60104NW-24T5F</basicUdiDi>
    <tradeName>Mycoplasma Genitalium Real Time PCR Kit</tradeName>
    <deviceName>Mycoplasma Genitalium Real Time PCR Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010803</emdnCode>
    <emdnDescription>MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JB(Z)60104NW-24T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:22:07.951Z</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>
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  <row>
    <udiDi>08684998275668</udiDi>
    <basicUdiDi>B-08684998275668</basicUdiDi>
    <tradeName>LyoSens  Mycoplasma genitalium qPCR Kit</tradeName>
    <deviceName>Mycoplasma genitalium qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010501080302</emdnCode>
    <emdnDescription>UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO58</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:21:38.784Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387212632</udiDi>
    <basicUdiDi>B-08684387212632</basicUdiDi>
    <tradeName>RevoDx Mycoplasma pneumoniae qPCR Kit</tradeName>
    <deviceName>RevoDx Mycoplasma pneumoniae qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010501080301</emdnCode>
    <emdnDescription>MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202328-100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:54:13.195Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387212625</udiDi>
    <basicUdiDi>B-08684387212625</basicUdiDi>
    <tradeName>RevoDx Mycoplasma pneumoniae qPCR Kit</tradeName>
    <deviceName>RevoDx Mycoplasma pneumoniae qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010501080301</emdnCode>
    <emdnDescription>MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202328-25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:54:12.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548259813</udiDi>
    <basicUdiDi>B-08683548259813</basicUdiDi>
    <tradeName>LyoSens Ureaplasma parvum Detection qPCR Kit</tradeName>
    <deviceName>Ureaplasma parvum Detection qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010803</emdnCode>
    <emdnDescription>MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO60</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:21:26.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548259240</udiDi>
    <basicUdiDi>B-08683548259240</basicUdiDi>
    <tradeName>LyoSens  Mycoplasma pneumoniae qPCR Kit</tradeName>
    <deviceName>Mycoplasma pneumoniae qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010501080301</emdnCode>
    <emdnDescription>MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO34</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:20:32.505Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548257628</udiDi>
    <basicUdiDi>B-08683548257628</basicUdiDi>
    <tradeName>ChainFor™ Mycoplasma pneumoniae Detection qPCR Kit</tradeName>
    <deviceName>Mycoplasma pneumoniae Detection qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010803</emdnCode>
    <emdnDescription>MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFP61</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:16:39.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696304089</udiDi>
    <basicUdiDi>B-08595696304089</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ Mycoplasma pneumoniae PCR Kit</tradeName>
    <deviceName>GeneProof Mycoplasma pneumoniae PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010501080301</emdnCode>
    <emdnDescription>MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A58210</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:19.142Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696304003</udiDi>
    <basicUdiDi>B-08595696304003</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ Mycoplasma genitalium/hominis PCR Kit</tradeName>
    <deviceName>GeneProof Mycoplasma genitalium/hominis PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010501080302</emdnCode>
    <emdnDescription>UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A58122</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:10.395Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696302016</udiDi>
    <basicUdiDi>B-08595696302016</basicUdiDi>
    <tradeName>GeneProof Mycoplasma hominis MC PCR Kit</tradeName>
    <deviceName>GeneProof Mycoplasma hominis MC PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010501080302</emdnCode>
    <emdnDescription>UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MH/MC/190</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:31.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696302009</udiDi>
    <basicUdiDi>B-08595696302009</basicUdiDi>
    <tradeName>GeneProof Mycoplasma hominis MC PCR Kit</tradeName>
    <deviceName>GeneProof Mycoplasma hominis MC PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010501080302</emdnCode>
    <emdnDescription>UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MH/MC/038</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:30.286Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696301989</udiDi>
    <basicUdiDi>B-08595696301989</basicUdiDi>
    <tradeName>GeneProof Mycoplasma genitalium MC PCR Kit</tradeName>
    <deviceName>GeneProof Mycoplasma genitalium MC PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010501080302</emdnCode>
    <emdnDescription>UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MG/MC/190</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:27.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696301972</udiDi>
    <basicUdiDi>B-08595696301972</basicUdiDi>
    <tradeName>GeneProof Mycoplasma genitalium MC PCR Kit</tradeName>
    <deviceName>GeneProof Mycoplasma genitalium MC PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010501080302</emdnCode>
    <emdnDescription>UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MG/MC/038</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:26.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594161952176</udiDi>
    <basicUdiDi>B-08594161952176</basicUdiDi>
    <tradeName>GeneProof Mycoplasma pneumoniae PCR Kit</tradeName>
    <deviceName>GeneProof Mycoplasma pneumoniae PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010501080301</emdnCode>
    <emdnDescription>MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MP/ISEX/100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:48:12.861Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594161952152</udiDi>
    <basicUdiDi>B-08594161952152</basicUdiDi>
    <tradeName>GeneProof Mycoplasma pneumoniae PCR Kit</tradeName>
    <deviceName>GeneProof Mycoplasma pneumoniae PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010501080301</emdnCode>
    <emdnDescription>MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MP/ISEX/025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:48:10.458Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976055490063</udiDi>
    <basicUdiDi>B-06976055490063</basicUdiDi>
    <tradeName>06976055490063</tradeName>
    <deviceName>Mycoplasma pneumoniae and Chlamydia pneumoniae nucleic acid detection kit (Real-time fluorescence PCR method)</deviceName>
    <manufacturerName>GUANGZHOU DEAOU GENE TECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000033028</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010803</emdnCode>
    <emdnDescription>MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:27:31.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975102280190</udiDi>
    <basicUdiDi>B-06975102280190</basicUdiDi>
    <tradeName>06975102280190</tradeName>
    <deviceName>GENEYE® Mycoplasma Pneumoniae Assay</deviceName>
    <manufacturerName>Suzhou GenDx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018830</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010501080301</emdnCode>
    <emdnDescription>MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RP003</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:56:38.585Z</lastUpdated>
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</eudamedExport>