<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08906213930009</udiDi>
    <basicUdiDi>89080153043B287NZ</basicUdiDi>
    <tradeName>TRUPCR® Respiratory Pathogen Panel Kit</tradeName>
    <deviceName>TRUPCR® Respiratory Pathogen Panel Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B287/C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:28:43.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>05745000468089</udiDi>
    <basicUdiDi>5745000468MFG010011FN</basicUdiDi>
    <tradeName>Nucleic Acid Extraction Kit</tradeName>
    <deviceName>Nucleic Acid Extraction Kit</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG010011</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:40:02.212Z</lastUpdated>
  </row>
  <row>
    <udiDi>04793002939008</udiDi>
    <basicUdiDi>4793002939BactfastDZ</basicUdiDi>
    <tradeName>Bactfast</tradeName>
    <deviceName>Bactfast Assay for ONT Sequencing</deviceName>
    <manufacturerName>Credence Genomics Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>LK-MF-000045860</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CGNBF001.100</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:08:40.948Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684595034941</udiDi>
    <basicUdiDi>868511580PCR81JL</basicUdiDi>
    <tradeName>LyoSens™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO815WS24</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T19:47:53.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908015304262</udiDi>
    <basicUdiDi>89080153043B287NZ</basicUdiDi>
    <tradeName>TRUPCR® Respiratory Pathogen Panel Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B287</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:41.282Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908015304279</udiDi>
    <basicUdiDi>89080153043B287NZ</basicUdiDi>
    <tradeName>TRUPCR® Respiratory Pathogen Panel Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B288</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:40.539Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-U-200-0243S</udiDi>
    <basicUdiDi>B-U-200-0243S</basicUdiDi>
    <tradeName>Micro-Dx™ CE IVD</tradeName>
    <deviceName>Micro-Dx™ CE IVD</deviceName>
    <manufacturerName>Molzym GmbH &amp; Co.KG</manufacturerName>
    <manufacturerSrn>DE-MF-000037419</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>U-200-024</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:25:48.594Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-U-050-04857</udiDi>
    <basicUdiDi>B-U-050-04857</basicUdiDi>
    <tradeName>UMD-SelectNA™ CE IVD</tradeName>
    <deviceName>UMD-SelectNA™ CE IVD</deviceName>
    <manufacturerName>Molzym GmbH &amp; Co.KG</manufacturerName>
    <manufacturerSrn>DE-MF-000037419</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>U-050-048</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:25:41.162Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-U-050-0244R</udiDi>
    <basicUdiDi>B-U-050-0244R</basicUdiDi>
    <tradeName>UMD-SelectNA™ CE IVD</tradeName>
    <deviceName>UMD-SelectNA™ CE IVD</deviceName>
    <manufacturerName>Molzym GmbH &amp; Co.KG</manufacturerName>
    <manufacturerSrn>DE-MF-000037419</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>U-050-024</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:25:39.833Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-U-010-0483K</udiDi>
    <basicUdiDi>B-U-010-0483K</basicUdiDi>
    <tradeName>SepsiTest™-UMD CE IVD</tradeName>
    <deviceName>SepsiTest™-UMD CE IVD</deviceName>
    <manufacturerName>Molzym GmbH &amp; Co.KG</manufacturerName>
    <manufacturerSrn>DE-MF-000037419</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>U-010-048</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:25:38.766Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-JB60103NW-50TS6</udiDi>
    <basicUdiDi>B-JB60103NW-50TS6</basicUdiDi>
    <tradeName>Ureaplasma Urealyticum Real Time PCR Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JB60103NW-50T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:22:39.948Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EU0100030050EN</udiDi>
    <basicUdiDi>B-EU0100030050EN</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>Monkeypox Virus Nucleic Acid Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU0100030050</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:08:24.354Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-81649002CMTBRIFZK01TFQX</udiDi>
    <basicUdiDi>B-81649002CMTBRIFZK01TFQX</basicUdiDi>
    <tradeName>D-81649002CMTBRIFZK01TFQX</tradeName>
    <deviceName>GeneStream MTB/RIF Controls</deviceName>
    <manufacturerName>Healgen Life Science LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043017</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMTBRIFZK01-AHG4E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:05:05.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-81649002CMTBRIF01AT29X</udiDi>
    <basicUdiDi>B-81649002CMTBRIF01AT29X</basicUdiDi>
    <tradeName>D-81649002CMTBRIF01AT29X</tradeName>
    <deviceName>GeneStream MTB/RIF Assay</deviceName>
    <manufacturerName>Healgen Life Science LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043017</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMTBRIF01A-AHG4E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:05:04.861Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-81649002CMTBMDRZK01SVRN</udiDi>
    <basicUdiDi>B-81649002CMTBMDRZK01SVRN</basicUdiDi>
    <tradeName>D-81649002CMTBMDRZK01SVRN</tradeName>
    <deviceName>GeneStream MTB MDR Controls</deviceName>
    <manufacturerName>Healgen Life Science LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043017</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMTBMDRZK01-AHG4E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:05:03.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-81649002CMTBMDR01ARWB9</udiDi>
    <basicUdiDi>B-81649002CMTBMDR01ARWB9</basicUdiDi>
    <tradeName>D-81649002CMTBMDR01ARWB9</tradeName>
    <deviceName>GeneStream MTB MDR Assay</deviceName>
    <manufacturerName>Healgen Life Science LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043017</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMTBMDR01A-AHG4E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:05:00.871Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-81649002CMTB01AGXXR</udiDi>
    <basicUdiDi>B-81649002CMTB01AGXXR</basicUdiDi>
    <tradeName>D-81649002CMTB01AGXXR</tradeName>
    <deviceName>GeneStream MTB Assay</deviceName>
    <manufacturerName>Healgen Life Science LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043017</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMTB01A-AHG4E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:04:59.259Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-81649002AHTV01GMRU</udiDi>
    <basicUdiDi>B-81649002AHTV01GMRU</basicUdiDi>
    <tradeName>D-81649002AHTV01GMRU</tradeName>
    <deviceName>Hantavirus Detection Kit(Fluorescence PCR)</deviceName>
    <manufacturerName>Healgen Life Science LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043017</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"AHTV01-AHG48E， AHTV01-AHG96E"</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:00:19.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-81649002AHTV01DJE35</udiDi>
    <basicUdiDi>B-81649002AHTV01DJE35</basicUdiDi>
    <tradeName>D-81649002AHTV01DJE35</tradeName>
    <deviceName>Hantavirus Fluorescence PCR Kit (Lyophilized)</deviceName>
    <manufacturerName>Healgen Life Science LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043017</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AHTV01D-AHG48E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:00:19.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-81649002ADZCOM01D7667</udiDi>
    <basicUdiDi>B-81649002ADZCOM01D7667</basicUdiDi>
    <tradeName>D-81649002ADZCOM01D7667</tradeName>
    <deviceName>DENV/ZIKV/CHIKV/OROV/MAYV 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>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADZCOM01D-AHG48E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:59:35.078Z</lastUpdated>
  </row>
</eudamedExport>