<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06970581432092</udiDi>
    <basicUdiDi>B-06970581432092</basicUdiDi>
    <tradeName>Accu-Tell® Syphilis Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Accu-Tell® Rapid Syphilis Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-STD-B60</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:48:43.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970581432085</udiDi>
    <basicUdiDi>B-06970581432085</basicUdiDi>
    <tradeName>Accu-Tell® Syphilis Strip (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Accu-Tell® Rapid Syphilis Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-STD-A60</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:48:42.737Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970581430630</udiDi>
    <basicUdiDi>B-06970581430630</basicUdiDi>
    <tradeName>Accu-Tell®H. pylori IgG Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Accu-Tell® H. pylori IgG Cassette</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B13</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:42:49.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970581430623</udiDi>
    <basicUdiDi>B-06970581430623</basicUdiDi>
    <tradeName>Accu-Tell® H. pylori IgG/IgM/IgA Strip （Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Accu-Tell® H. pylori IgG/IgM/IgA Strip</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-A385</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:42:48.484Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970581430616</udiDi>
    <basicUdiDi>B-06970581430616</basicUdiDi>
    <tradeName>Accu-Tell® H. pylori IgG/IgM/IgA Cassette(Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Accu-Tell® H. pylori IgG/IgM/IgA Cassette</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B385</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:42:42.478Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970581430487</udiDi>
    <basicUdiDi>B-06970581430487</basicUdiDi>
    <tradeName>Accu-Tell® H. pylori Antigen Cassette (Feces)</tradeName>
    <deviceName>Accu-Tell® Rapid H. pylori Antigen Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B76</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:42:22.055Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970581430258</udiDi>
    <basicUdiDi>B-06970581430258</basicUdiDi>
    <tradeName>Accu-Tell® Strep A Cassette (Throat Swab)</tradeName>
    <deviceName>Accu-Tell® Rapid Strep A Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:42:04.044Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970277511179</udiDi>
    <basicUdiDi>B-06970277511179</basicUdiDi>
    <tradeName>Syphilis Rapid Test Cassette</tradeName>
    <deviceName>Syphilis Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISY-402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:37:39.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970277511049</udiDi>
    <basicUdiDi>B-06970277511049</basicUdiDi>
    <tradeName>H.pylori Antigen Rapid Test Cassette (Feces)</tradeName>
    <deviceName>H.pylori Antigen Rapid Test Cassette (Feces)</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHP-602</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:37:25.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970277510493</udiDi>
    <basicUdiDi>B-06970277510493</basicUdiDi>
    <tradeName>06970277510493</tradeName>
    <deviceName>Strep A Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IST-502</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:37:09.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954414702378</udiDi>
    <basicUdiDi>B-06954414702378</basicUdiDi>
    <tradeName>H. pylori Fast Test Kit (Immunofluorescence Assay)</tradeName>
    <deviceName>H. pylori Fast Test Kit (Immunofluorescence Assay)</deviceName>
    <manufacturerName>Getein Biotech, Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017986</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T15:25:55.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952999408838</udiDi>
    <basicUdiDi>B-06952999408838</basicUdiDi>
    <tradeName>06952999408838</tradeName>
    <deviceName>One Step H.pylori Antigen Test Device (Feces)</deviceName>
    <manufacturerName>Abon Biopharm(Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000009171</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHP-602</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T10:52:05.481Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952999408821</udiDi>
    <basicUdiDi>B-06952999408821</basicUdiDi>
    <tradeName>06952999408821</tradeName>
    <deviceName>One Step H.pylori Antigen Test Device (Feces)</deviceName>
    <manufacturerName>Abon Biopharm(Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000009171</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHP-602</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T10:52:04.470Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952999407435</udiDi>
    <basicUdiDi>B-06952999407435</basicUdiDi>
    <tradeName>06952999407435</tradeName>
    <deviceName>Syphilis Ultra Rapid Test Device (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>Abon Biopharm(Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000009171</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISY-U402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T10:51:52.362Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952999404342</udiDi>
    <basicUdiDi>B-06952999404342</basicUdiDi>
    <tradeName>06952999404342</tradeName>
    <deviceName>One Step H. pylori Test Device ( Serum/Plasma)</deviceName>
    <manufacturerName>Abon Biopharm(Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000009171</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHP-302</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-06-28T10:47:47.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804832063</udiDi>
    <basicUdiDi>69528048A4671002Q</basicUdiDi>
    <tradeName>Mycoplasma Pneumoniae Antigen Rapid Test Device</tradeName>
    <deviceName>Mycoplasma Pneumoniae Antigen Rapid Test Device</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090109</emdnCode>
    <emdnDescription>STREP. PNEUMONIAE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A46710</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:33:24.513Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804827014</udiDi>
    <basicUdiDi>B-06952804827014</basicUdiDi>
    <tradeName>Strep B Rapid Test</tradeName>
    <deviceName>Strep B Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090104</emdnCode>
    <emdnDescription>STREP. B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STB-S23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:32:12.177Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804827007</udiDi>
    <basicUdiDi>B-06952804827007</basicUdiDi>
    <tradeName>Strep A Rapid Test</tradeName>
    <deviceName>Strep A Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STA-S23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:32:10.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804825638</udiDi>
    <basicUdiDi>69528048A463101ZT</basicUdiDi>
    <tradeName>06952804825638</tradeName>
    <deviceName>Strep A Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A4631011, A46310120, A46310140, A4631021, A46310220, A46310240; A46300120, A46300140, A46300220, A46300240</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:32:06.185Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804819354</udiDi>
    <basicUdiDi>B-06952804819354</basicUdiDi>
    <tradeName>H. pylori Antibodies Rapid Test</tradeName>
    <deviceName>H. pylori Antibodies Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP-W23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:31:59.022Z</lastUpdated>
  </row>
</eudamedExport>