<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06952999410008</udiDi>
    <basicUdiDi>69529994HBV0001X4</basicUdiDi>
    <tradeName>ABON™</tradeName>
    <deviceName>ABON™ HBsAg Hepatitis B Surface Antigen 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 Sınıf D</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090201</emdnCode>
    <emdnDescription>HBSAG - RT &amp; POC</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>IHBsg-402001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:54:50.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>16952999401317</udiDi>
    <basicUdiDi>B-16952999401317</basicUdiDi>
    <tradeName>16952999401317</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IST-501</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T03:44:41.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>16952999401324</udiDi>
    <basicUdiDi>B-16952999401324</basicUdiDi>
    <tradeName>16952999401324</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IST-502</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T03:44:41.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>16952999401331</udiDi>
    <basicUdiDi>B-16952999401331</basicUdiDi>
    <tradeName>16952999401331</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UPK009C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T03:44:41.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952999408944</udiDi>
    <basicUdiDi>B-06952999408944</basicUdiDi>
    <tradeName>06952999408944</tradeName>
    <deviceName>FOB One Step Fecal Occult Blood 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>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TFO-602</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T10:52:14.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952999408937</udiDi>
    <basicUdiDi>B-06952999408937</basicUdiDi>
    <tradeName>06952999408937</tradeName>
    <deviceName>FOB One Step Fecal Occult Blood 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>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TFO-602</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T10:52:12.828Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952999408845</udiDi>
    <basicUdiDi>B-06952999408845</basicUdiDi>
    <tradeName>06952999408845</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>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHP-602</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T10:52:11.466Z</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>06952999408371</udiDi>
    <basicUdiDi>B-06952999408371</basicUdiDi>
    <tradeName>06952999408371</tradeName>
    <deviceName>hCG One Step Pregnancy Test Device (Urine/Serum)</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>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-202</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T10:52:03.060Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952999407541</udiDi>
    <basicUdiDi>B-06952999407541</basicUdiDi>
    <tradeName>06952999407541</tradeName>
    <deviceName>ABON™ Urine Test Drug Screen Dip Card</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>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DOA-164</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T10:52:02.192Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952999407534</udiDi>
    <basicUdiDi>B-06952999407534</basicUdiDi>
    <tradeName>06952999407534</tradeName>
    <deviceName>ABON™ Urine Test Drug Screen Dip Card</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>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DOA-164</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T10:51:56.066Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952999407510</udiDi>
    <basicUdiDi>B-06952999407510</basicUdiDi>
    <tradeName>06952999407510</tradeName>
    <deviceName>HCV Hepatitis C Virus Rapid 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 Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090202</emdnCode>
    <emdnDescription>HCV ANTIBODY -RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHC-302</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T10:51:54.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952999407497</udiDi>
    <basicUdiDi>B-06952999407497</basicUdiDi>
    <tradeName>06952999407497</tradeName>
    <deviceName>HIV 1/2/O Tri-line Human Immunodeficiency Virus 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 Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090302</emdnCode>
    <emdnDescription>HIV 1 / 2 - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHI-T402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T10:51:53.808Z</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>06952999407428</udiDi>
    <basicUdiDi>B-06952999407428</basicUdiDi>
    <tradeName>06952999407428</tradeName>
    <deviceName>HBsAg Hepatitis B Surface Antigen 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 Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090201</emdnCode>
    <emdnDescription>HBSAG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHBsg-402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T10:51:46.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952999406278</udiDi>
    <basicUdiDi>B-06952999406278</basicUdiDi>
    <tradeName>06952999406278</tradeName>
    <deviceName>ABON™ Urine Test Drug Screen Dip Card</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>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DUD-164</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T10:51:45.481Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952999406261</udiDi>
    <basicUdiDi>B-06952999406261</basicUdiDi>
    <tradeName>06952999406261</tradeName>
    <deviceName>ABON™ Urine Test Drug Screen Dip Card</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>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DUD-164</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T10:51:44.009Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952999406254</udiDi>
    <basicUdiDi>B-06952999406254</basicUdiDi>
    <tradeName>06952999406254</tradeName>
    <deviceName>ABON™ Urine Test Drug Screen Dip Card</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>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DUD-164</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T10:51:42.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952999406247</udiDi>
    <basicUdiDi>B-06952999406247</basicUdiDi>
    <tradeName>06952999406247</tradeName>
    <deviceName>ABON™ Urine Test Drug Screen Dip Card</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>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DUD-134</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T10:51:36.638Z</lastUpdated>
  </row>
</eudamedExport>