<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06936415900762</udiDi>
    <basicUdiDi>69449040004S-PCT*******M3</basicUdiDi>
    <tradeName>PCT Control</tradeName>
    <deviceName>Procalcitonin(CLIA)、PCT Calibrators、PCT Control</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152008</emdnCode>
    <emdnDescription>CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-010248-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:37:09.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273219036</udiDi>
    <basicUdiDi>50552732BAVB12C173QK</basicUdiDi>
    <tradeName>ACTIVE VITAMIN B12 CONTROL LEVEL 2 (Active Vitamin B12 CONTROL 2)</tradeName>
    <deviceName>ACTIVE VITAMIN B12 CONTROL</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152006</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VB10525</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:46:50.060Z</lastUpdated>
  </row>
  <row>
    <udiDi>14987481164489</udiDi>
    <basicUdiDi>49874814987481164413UA</basicUdiDi>
    <tradeName>μTASWako DCP Control L</tradeName>
    <deviceName>μTASWako DCP, μTASWako DCP Calibrator Set, μTASWako DCP Control L, μTASWako DCP Control H</deviceName>
    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Wako Chemicals Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011552</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>995-61301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:42:58.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>14987481164441</udiDi>
    <basicUdiDi>49874814987481164390UP</basicUdiDi>
    <tradeName>μTASWako AFP-L3 Control L</tradeName>
    <deviceName>μTASWako AFP-L3, μTASWako AFP-L3 Calibrator Set, μTASWako AFP-L3 Control L, μTASWako AFP-L3 Control H</deviceName>
    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Wako Chemicals Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011552</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>997-61001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:42:55.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987595302107</udiDi>
    <basicUdiDi>4987595PF0221CWJ</basicUdiDi>
    <tradeName>PATHFAST B･R･A･H･M･S PCT Control</tradeName>
    <deviceName>PATHFAST B·R·A·H·M·S PCT Control</deviceName>
    <manufacturerName>PHC Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000008516</manufacturerSrn>
    <authorisedRepresentativeName>PHC Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002692</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30210</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:41:02.998Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987595302008</udiDi>
    <basicUdiDi>4987595PF0201CW8</basicUdiDi>
    <tradeName>PATHFAST Presepsin Control</tradeName>
    <deviceName>PATHFAST Presepsin Control</deviceName>
    <manufacturerName>PHC Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000008516</manufacturerSrn>
    <authorisedRepresentativeName>PHC Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002692</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30200</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:41:02.691Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719879495003</udiDi>
    <basicUdiDi>471987949E103047Q</basicUdiDi>
    <tradeName>DNlite uPTM-FetA ELISA Kit - Controls</tradeName>
    <deviceName>DNlite uPTM-FetA ELISA Kit - Controls</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8105001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:32:44.791Z</lastUpdated>
  </row>
  <row>
    <udiDi>00856743007062</udiDi>
    <basicUdiDi>0856743007MDI02406D</basicUdiDi>
    <tradeName>00856743007062</tradeName>
    <deviceName>Mycophenolic Acid Control</deviceName>
    <manufacturerName>More Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000019469</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>240</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:41:35.988Z</lastUpdated>
  </row>
  <row>
    <udiDi>00856743007055</udiDi>
    <basicUdiDi>0856743007MDI020265</basicUdiDi>
    <tradeName>00856743007055</tradeName>
    <deviceName>Cyclosporine C2 Control</deviceName>
    <manufacturerName>More Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000019469</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>202</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:41:19.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850624008575</udiDi>
    <basicUdiDi>0850624008CCEtG302HJ</basicUdiDi>
    <tradeName>Ethyl Glucuronide 200 Control Set</tradeName>
    <deviceName>Ethyl Glucuronide Calibrators and Controls</deviceName>
    <manufacturerName>Lin-Zhi International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003373</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152009</emdnCode>
    <emdnDescription>CONTROLS FOR NARCOTICS / TOXICOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09976507190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:33:29.957Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414649887</udiDi>
    <basicUdiDi>0405686902371VP</basicUdiDi>
    <tradeName>Atellica IM VitDII Quality Control (VitDII QC)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_KIT_VitDII QC</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>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11698632</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:37:37.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414635453</udiDi>
    <basicUdiDi>0405686902257VQ</basicUdiDi>
    <tradeName>ADVIA Centaur NfL Quality Control (NfL QC)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_sNfL Control</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>W0102152011</emdnCode>
    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11553994</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:37:07.349Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414615400</udiDi>
    <basicUdiDi>0405686902180VE</basicUdiDi>
    <tradeName>N aTNFa Controls ADA</tradeName>
    <deviceName>IVDR_27_MAR EB_B_N_aTNFa_Con_ADA_ETA_INF</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873740</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:36:51.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414602899</udiDi>
    <basicUdiDi>0405686901861W6</basicUdiDi>
    <tradeName>ADVIA Centaur NT-proBNP (PBNP) Master Curve Material (MCM)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_PBNP MCM</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>W0102152004</emdnCode>
    <emdnDescription>CARDIAC MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10994359</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:36:06.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414592350</udiDi>
    <basicUdiDi>0405686901766WB</basicUdiDi>
    <tradeName>ADVIA Centaur Intact Parathyroid Hormone (PTH) Quality Control</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_PTH QC</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>W0102152008</emdnCode>
    <emdnDescription>CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10699156</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:34:32.792Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414591278</udiDi>
    <basicUdiDi>0405686901765W9</basicUdiDi>
    <tradeName>ADVIA Centaur Intact Parathyroid Hormone MCM</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_PTH MCM</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>W0102152008</emdnCode>
    <emdnDescription>CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10698597</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:34:31.990Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414286914</udiDi>
    <basicUdiDi>0405686902267VT</basicUdiDi>
    <tradeName>ADVIA Centaur AMH QC Kit</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_CDx_REAG_AMH QC</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>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11205264</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:33:46.847Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414246543</udiDi>
    <basicUdiDi>0405686901862W8</basicUdiDi>
    <tradeName>ADVIA Centaur BRAHMS Procalcitonin (PCT) Quality Control</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_PCT Quality Control</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>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11202698</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:33:36.462Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414027944</udiDi>
    <basicUdiDi>0405686901901VR</basicUdiDi>
    <tradeName>Emit II Plus Specialty Multi Drug Calibrator/Control Level 4</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_Spl Multi Drug Cals/Ctls Levels 1-4</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10720815</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:32:31.522Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414015606</udiDi>
    <basicUdiDi>0405686902129VE</basicUdiDi>
    <tradeName>ADVIA Centaur PlGF Quality Control (PlGF QC)</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_C_REAG_PlGF Quality Control</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10998064</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:32:30.731Z</lastUpdated>
  </row>
</eudamedExport>