<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-ST12N3</udiDi>
    <basicUdiDi>B-ST12N3</basicUdiDi>
    <tradeName>Cowingene Mycoplasma Genitalium and Mycoplasma Hominis Detection Kit</tradeName>
    <deviceName>Cowingene Mycoplasma Genitalium and Mycoplasma Hominis Detection Kit</deviceName>
    <manufacturerName>Taizhou Cowingene Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042619</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010501080302</emdnCode>
    <emdnDescription>UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST12021X, ST12022X, ST12023W</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:43:32.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ST06N8</udiDi>
    <basicUdiDi>B-ST06N8</basicUdiDi>
    <tradeName>Cowingene Group B Streptococcus Detection Kit</tradeName>
    <deviceName>Cowingene Group B Streptococcus Detection Kit</deviceName>
    <manufacturerName>Taizhou Cowingene Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042619</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011104</emdnCode>
    <emdnDescription>STREP. B DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST06011X, ST06012X, ST06013W</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:42:19.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SAC2022021E6</udiDi>
    <basicUdiDi>B-SAC2022021E6</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>H. pylori Antibody Test (Colloidal Gold)</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAC2022021</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:35:32.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SAC2022020E4</udiDi>
    <basicUdiDi>B-SAC2022020E4</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>H. pylori Antibody Test (Colloidal Gold)</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAC2022020</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:35:27.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SAC2022019EK</udiDi>
    <basicUdiDi>B-SAC2022019EK</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>H. pylori Antibody Test (Colloidal Gold)</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAC2022019</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:35:27.147Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SAC2022004E6</udiDi>
    <basicUdiDi>B-SAC2022004E6</basicUdiDi>
    <tradeName>BGI</tradeName>
    <deviceName>H. pylori Antibody Test (Colloidal Gold)</deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010402</emdnCode>
    <emdnDescription>H. PYLORI ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAC2022004</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:34:50.658Z</lastUpdated>
  </row>
  <row>
    <udiDi>111816978037</udiDi>
    <basicUdiDi>PP12579.SWIFTX.MEDIA.26</basicUdiDi>
    <tradeName>Releaser</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xpedite Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000020021</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011699</emdnCode>
    <emdnDescription>BACTERIOLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SGR-25-IVD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:51:35.612Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PL10011MM</udiDi>
    <basicUdiDi>B-PL10011MM</basicUdiDi>
    <tradeName>MYCOKIT SERO</tradeName>
    <deviceName>MYCOKIT SERO</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PL10011</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-14T06:45:48.404Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MycoplasmaIgMLE</udiDi>
    <basicUdiDi>B-MycoplasmaIgMLE</basicUdiDi>
    <tradeName>Mycoplasma IgM Rapid Test</tradeName>
    <deviceName>Mycoplasma IgM 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>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Cassette</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:19:13.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MTB-K-0074D</udiDi>
    <basicUdiDi>B-MTB-K-0074D</basicUdiDi>
    <tradeName>Logix Smart MTB Test Kit</tradeName>
    <deviceName>Logix Smart MTB Test Kit</deviceName>
    <manufacturerName>Co-Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000036425</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTB-K-007</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:18:12.330Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MS01349PZ</udiDi>
    <basicUdiDi>B-MS01349PZ</basicUdiDi>
    <tradeName>MYCO WELL D-ONE LIQUI SCREEN</tradeName>
    <deviceName>MYCO WELL D-ONE LIQUI SCREEN</deviceName>
    <manufacturerName>C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000010738</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010899</emdnCode>
    <emdnDescription>MYCOPLASMA / UREAPLASMA  REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS01349</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:13:50.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-TP-02100UY</udiDi>
    <basicUdiDi>B-KR-TP-02100UY</basicUdiDi>
    <tradeName>INNODX TP Ab CMIA</tradeName>
    <deviceName>INNODX TP Ab CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-TP-01200C</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:46:16.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-TB-IGRA-01050W7U</udiDi>
    <basicUdiDi>B-KR-TB-IGRA-01050W7U</basicUdiDi>
    <tradeName>INNODX TB-IGRA CMIA</tradeName>
    <deviceName>INNODX TB-IGRA CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010704</emdnCode>
    <emdnDescription>TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-TB-IGRA-01050W</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:46:13.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-TB-IGRA-01020C65</udiDi>
    <basicUdiDi>B-KR-TB-IGRA-01020C65</basicUdiDi>
    <tradeName>INNODX TB-IGRA CMIA</tradeName>
    <deviceName>INNODX TB-IGRA CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010704</emdnCode>
    <emdnDescription>TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-TB-IGRA-01020C</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:46:10.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KC3C2</udiDi>
    <basicUdiDi>B-KC3C2</basicUdiDi>
    <tradeName>Chlamydia CEL PN IFA</tradeName>
    <deviceName>Chlamydia CEL PN IFA (50T)</deviceName>
    <manufacturerName>Cellabs Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000030640</manufacturerSrn>
    <authorisedRepresentativeName>WMDE B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002062</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010112</emdnCode>
    <emdnDescription>CHLAMYDIA PNEUMONIAE ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KC3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:38:52.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KC3-BTJ</udiDi>
    <basicUdiDi>B-KC3-BTJ</basicUdiDi>
    <tradeName>Chlamydia CEL PN IFA</tradeName>
    <deviceName>Chlamydia CEL PN IFA (200T)</deviceName>
    <manufacturerName>Cellabs Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000030640</manufacturerSrn>
    <authorisedRepresentativeName>WMDE B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002062</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010112</emdnCode>
    <emdnDescription>CHLAMYDIA PNEUMONIAE ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KC3-B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:38:49.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KC1BW</udiDi>
    <basicUdiDi>B-KC1BW</basicUdiDi>
    <tradeName>Chlamydia CEL IFA</tradeName>
    <deviceName>Chlamydia CEL IFA Kit (50T)</deviceName>
    <manufacturerName>Cellabs Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000030640</manufacturerSrn>
    <authorisedRepresentativeName>WMDE B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002062</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010107</emdnCode>
    <emdnDescription>CHLAMYDIA TRACHOMATIS ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KC1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:38:47.797Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KC1-BT8</udiDi>
    <basicUdiDi>B-KC1-BT8</basicUdiDi>
    <tradeName>Chlamydia CEL IFA (200T)</tradeName>
    <deviceName>Chlamydia CEL IFA</deviceName>
    <manufacturerName>Cellabs Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000030640</manufacturerSrn>
    <authorisedRepresentativeName>WMDE B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002062</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010107</emdnCode>
    <emdnDescription>CHLAMYDIA TRACHOMATIS ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KC1-B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:38:46.996Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-JB60108NW-50TUT</udiDi>
    <basicUdiDi>B-JB60108NW-50TUT</basicUdiDi>
    <tradeName>Treponema Pallidum 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>W0105010305</emdnCode>
    <emdnDescription>SYPHILIS DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JB60108NW-50T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:22:42.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-JB60108NW-25TUT</udiDi>
    <basicUdiDi>B-JB60108NW-25TUT</basicUdiDi>
    <tradeName>Treponema Pallidum 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>W0105010305</emdnCode>
    <emdnDescription>SYPHILIS DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JB60108NW-25T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:22:41.541Z</lastUpdated>
  </row>
</eudamedExport>