<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04049055002894</udiDi>
    <basicUdiDi>40490550300001061UB</basicUdiDi>
    <tradeName>GXT NA Extraction Kit VER 1.0</tradeName>
    <deviceName>GXT NA Extraction Kit VER 1.0</deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12.08.02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:47:32.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049055002849</udiDi>
    <basicUdiDi>40490550300001055UG</basicUdiDi>
    <tradeName>FluoroLyse VER 1.0</tradeName>
    <deviceName>FluoroLyse VER 1.0</deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>51696</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:47:29.736Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049055002825</udiDi>
    <basicUdiDi>40490550300001065UK</basicUdiDi>
    <tradeName>SpheroLyse VER 1.0</tradeName>
    <deviceName>SpheroLyse® VER 1.0</deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>51796</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:47:28.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049055002641</udiDi>
    <basicUdiDi>40490550300001078UU</basicUdiDi>
    <tradeName>TwinCubator</tradeName>
    <deviceName>TwinCubator</deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050101</emdnCode>
    <emdnDescription>NUCLEIC ACID HYBRIDIZATION UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7025009</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:47:27.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049055002610</udiDi>
    <basicUdiDi>40490550300001000TP</basicUdiDi>
    <tradeName>GenoType MTBDRplus VER 2.0</tradeName>
    <deviceName>GenoType MTBDRplus VER 2.0</deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>304A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:47:25.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049055002511</udiDi>
    <basicUdiDi>40490550300001059UQ</basicUdiDi>
    <tradeName>GXT Blood Extraction Kit VER 2.0</tradeName>
    <deviceName>GXT Blood Extraction Kit VER 2.0</deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12.07.02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:47:23.349Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049055002504</udiDi>
    <basicUdiDi>40490550300001076UQ</basicUdiDi>
    <tradeName>GenoXtract®</tradeName>
    <deviceName>GenoXtract®</deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069099</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.31.01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:47:21.748Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049055001231</udiDi>
    <basicUdiDi>40490550300001057UL</basicUdiDi>
    <tradeName>GenoLyse VER 1.0</tradeName>
    <deviceName>GenoLyse VER 1.0</deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>51610</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:47:20.936Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049055001095</udiDi>
    <basicUdiDi>40490550300001068UR</basicUdiDi>
    <tradeName>Reagent Set for DNA•STRIP Kits</tradeName>
    <deviceName>Reagent Set for DNA•STRIP Kits</deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</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>R003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:47:19.366Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049055000500</udiDi>
    <basicUdiDi>40490550300001077US</basicUdiDi>
    <tradeName>GT-Blot 48</tradeName>
    <deviceName>GT-Blot 48</deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050101</emdnCode>
    <emdnDescription>NUCLEIC ACID HYBRIDIZATION UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1003/1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:47:16.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049055000036</udiDi>
    <basicUdiDi>40490550300001056UJ</basicUdiDi>
    <tradeName>GENO•CARD VER 1.0</tradeName>
    <deviceName>GENO•CARD VER 1.0</deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010199</emdnCode>
    <emdnDescription>VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G00196</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:47:15.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049055002627</udiDi>
    <basicUdiDi>40490550300001000TP</basicUdiDi>
    <tradeName>GenoType MTBDRplus VER 2.0</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30496A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T19:41:18.698Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049055003952</udiDi>
    <basicUdiDi>40490550300001109UE</basicUdiDi>
    <tradeName>Analyzer LA Gastrointestinal PCR 1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050182</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1909944</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T19:41:17.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049055003969</udiDi>
    <basicUdiDi>40490550300001109UE</basicUdiDi>
    <tradeName>Analyzer LA Gastrointestinal PCR 2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050182</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1909945</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T19:41:17.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049055003976</udiDi>
    <basicUdiDi>40490550300001109UE</basicUdiDi>
    <tradeName>Analyzer GENERIC HIV-1 VL 2.0 FCXT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050182</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1913150</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T19:41:17.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049055003983</udiDi>
    <basicUdiDi>40490550300001109UE</basicUdiDi>
    <tradeName>Analyzer FT MTBDR 2.0 FC XT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050182</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1915203</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T19:41:17.572Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049055004003</udiDi>
    <basicUdiDi>40490550300001109UE</basicUdiDi>
    <tradeName>Analyzer LA Gastrointestinal 2 PCR 1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050182</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1915176</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T19:41:17.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049055004010</udiDi>
    <basicUdiDi>40490550300001109UE</basicUdiDi>
    <tradeName>Analyzer LA Gastrointestinal 2 PCR 2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050182</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1915177</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T19:41:17.512Z</lastUpdated>
  </row>
</eudamedExport>