<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00630414451077</udiDi>
    <basicUdiDi>0405686901557VY</basicUdiDi>
    <tradeName>ADVIA Centaur FOL Ascorbic Acid (lyophilized)/Ascorbic Acid Diluent</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_Fol Ascorbic Acid/Ascorbic Acid Dil</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10316877</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T19:48:26.712Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414175331</udiDi>
    <basicUdiDi>0405686901561VP</basicUdiDi>
    <tradeName>ADVIA Centaur IgE Diluent</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_REAG_IgE Diluent</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10309952</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T19:48:14.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414451558</udiDi>
    <basicUdiDi>0405686901839WD</basicUdiDi>
    <tradeName>ADVIA Centaur cPSA Pretreatment Reagent</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_cPSA Pretreatment</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10310384</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:39:30.690Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414175386</udiDi>
    <basicUdiDi>0405686901772W6</basicUdiDi>
    <tradeName>ADVIA Centaur T3/T4/VB12 Ancillary Reagent</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_T3/T4/VB12 Ancillary Reagent</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10309954</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:39:15.310Z</lastUpdated>
  </row>
  <row>
    <udiDi>B350GSD011600DIL0</udiDi>
    <basicUdiDi>++B350GSD011600DILQZ</basicUdiDi>
    <tradeName>GSD RPR Diluent</tradeName>
    <deviceName>GSD RPR Diluent</deviceName>
    <manufacturerName>Gold Standard Diagnostics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000027142</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GSD01-1600-DIL</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:20:29.844Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414600468</udiDi>
    <basicUdiDi>0405686900735VR</basicUdiDi>
    <tradeName>Atellica IM Insulin Diluent (IRI DIL)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_KIT_IRI_Dil</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995630</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:15:05.525Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414599397</udiDi>
    <basicUdiDi>0405686901561VP</basicUdiDi>
    <tradeName>Atellica IM Total IgE Diluent (tIgE DIL)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_REAG_IgE Diluent</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995616</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:15:00.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414599311</udiDi>
    <basicUdiDi>0405686901560VM</basicUdiDi>
    <tradeName>Atellica IM HCY DIL (diluent)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_REAG_HCY Diluent</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995608</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:14:59.036Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414599007</udiDi>
    <basicUdiDi>0405686901709VX</basicUdiDi>
    <tradeName>Atellica IM Fol DTT/REL (releasing agent)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_Folate DTT / Releasing Agent</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995576</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:14:40.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414598987</udiDi>
    <basicUdiDi>0405686901558W2</basicUdiDi>
    <tradeName>Atellica IM Fol DIL (diluent)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_REAG_Folate Diluent</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995574</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:14:32.770Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414598871</udiDi>
    <basicUdiDi>0405686901536VQ</basicUdiDi>
    <tradeName>Atellica IM Enhanced Estradiol Diluent (eE2 DIL)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_KIT_eE2 Diluent</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995563</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:14:32.478Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414597690</udiDi>
    <basicUdiDi>0405686901557VY</basicUdiDi>
    <tradeName>Atellica IM RBC Fol (ascorbic acid/diluent)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_Fol Ascorbic Acid/Ascorbic Acid Dil</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995440</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:14:17.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950334825036</udiDi>
    <basicUdiDi>69503348MTA007LV</basicUdiDi>
    <tradeName>Wash Buffer</tradeName>
    <deviceName>Wash Buffer</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60022001</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:47:55.699Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950334825029</udiDi>
    <basicUdiDi>69503348MTA006LT</basicUdiDi>
    <tradeName>Tube Cleaning Solution</tradeName>
    <deviceName>Tube Cleaning Solution</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>62005002</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:47:53.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950334825012</udiDi>
    <basicUdiDi>69503348MTA005LR</basicUdiDi>
    <tradeName>Substrate Tube Cleaning Solution</tradeName>
    <deviceName>Substrate Tube Cleaning Solution</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>62014001</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:47:51.692Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950334825005</udiDi>
    <basicUdiDi>69503348MTA004LP</basicUdiDi>
    <tradeName>Substrate Solution</tradeName>
    <deviceName>Substrate Solution</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>62031001</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:47:50.891Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950334824992</udiDi>
    <basicUdiDi>69503348MTA003LM</basicUdiDi>
    <tradeName>Concentrated Wash Buffer</tradeName>
    <deviceName>Concentrated Wash Buffer</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>62020001</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:47:49.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719879495027</udiDi>
    <basicUdiDi>471987949E103077W</basicUdiDi>
    <tradeName>DNlite uPTM-FetA ELISA Kit – 10x Wash Buffer</tradeName>
    <deviceName>DNlite uPTM-FetA ELISA Kit – 10x Wash Buffer</deviceName>
    <manufacturerName>Bio Preventive Medicine Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000022845</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8105003</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:32:47.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640146270207</udiDi>
    <basicUdiDi>0764014627TE1112QC</basicUdiDi>
    <tradeName>07640146270207</tradeName>
    <deviceName>TECO® Intact proinsulin ELISA wash solution</deviceName>
    <manufacturerName>TECOmedical AG</manufacturerName>
    <manufacturerSrn>CH-MF-000030341</manufacturerSrn>
    <authorisedRepresentativeName>EUROBIO SCIENTIFIC</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000023178</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TE1112</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:22:57.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768028434</udiDi>
    <basicUdiDi>0405686902050UY</basicUdiDi>
    <tradeName>IMMULITE 2000/XPi Probe Cleaning Kit</tradeName>
    <deviceName>IVDR_27_MAR EB_A_REAG_IMM_Probe_Cl</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10385229</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:38:09.948Z</lastUpdated>
  </row>
</eudamedExport>