<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>10845357029260</udiDi>
    <basicUdiDi>0845357001012VX</basicUdiDi>
    <tradeName>10845357029260</tradeName>
    <deviceName>KWIK-STIK™ and LYFO DISK™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040699</emdnCode>
    <emdnDescription>CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[01012U] KWIK-STIK™ H. valbyensis ATCC 58370™</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:23:54.472Z</lastUpdated>
  </row>
  <row>
    <udiDi>10845357029239</udiDi>
    <basicUdiDi>0845357001011VV</basicUdiDi>
    <tradeName>10845357029239</tradeName>
    <deviceName>KWIK-STIK™ and LYFO DISK™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040699</emdnCode>
    <emdnDescription>CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[01011U] KWIK-STIK™ Z. parabailii ATCC MYA-4549™</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:23:52.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382904440640</udiDi>
    <basicUdiDi>038290LVCGAXGWCJ</basicUdiDi>
    <tradeName>Kiestra</tradeName>
    <deviceName>BD Kiestra™ ID AST Calibrator Kit</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040699</emdnCode>
    <emdnDescription>CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>444064</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:34:44.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382904419530</udiDi>
    <basicUdiDi>038290LCYOQXQKHT</basicUdiDi>
    <tradeName>BD PhoenixSpec</tradeName>
    <deviceName>BD PhoenixSpec™ Calibrator 2.0 McFarland</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040699</emdnCode>
    <emdnDescription>CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>441953</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:34:31.001Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382904419516</udiDi>
    <basicUdiDi>038290KQWPIEEVK2</basicUdiDi>
    <tradeName>BD PhoenixSpec</tradeName>
    <deviceName>BD PhoenixSpec™ AP Calibrator Kit</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040699</emdnCode>
    <emdnDescription>CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>441951</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:34:25.357Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382904413569</udiDi>
    <basicUdiDi>038290MDEHOCIX4R</basicUdiDi>
    <tradeName>BD PhoenixSpec</tradeName>
    <deviceName>BD PhoenixSpec™ Calibrator 0.50 McFarland</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040699</emdnCode>
    <emdnDescription>CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>441356</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:34:06.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382904409111</udiDi>
    <basicUdiDi>038290JPJAIFED6H</basicUdiDi>
    <tradeName>BD PhoenixSpec</tradeName>
    <deviceName>BD PhoenixSpec™ Calibrator Kit</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040699</emdnCode>
    <emdnDescription>CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>440911</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:34:05.733Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382904413552</udiDi>
    <basicUdiDi>038290MBBSPWMT9Q</basicUdiDi>
    <tradeName>BD PhoenixSpec</tradeName>
    <deviceName>BD PhoenixSpec™ Calibrator 0.25 McFarland</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040699</emdnCode>
    <emdnDescription>CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>441355</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:34:04.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382902213017</udiDi>
    <basicUdiDi>038290KYXKQAGXPE</basicUdiDi>
    <tradeName>DIFCO</tradeName>
    <deviceName>BD Difco™ QC Antigen Salmonella O Group A, BD Difco™ QC Antigen Salmonella O Group D and BD Difco™ QC Antigen Salmonella Vi</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040699</emdnCode>
    <emdnDescription>CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>221301</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:32:24.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>00382902258513</udiDi>
    <basicUdiDi>038290DPRIOXWXFZ</basicUdiDi>
    <tradeName>DIFCO</tradeName>
    <deviceName>BD Difco™ Bordetella Pertussis Antigen</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040699</emdnCode>
    <emdnDescription>CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>225851</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:26:53.470Z</lastUpdated>
  </row>
  <row>
    <udiDi>10845357016772</udiDi>
    <basicUdiDi>084535700698AV</basicUdiDi>
    <tradeName>10845357016772</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040699</emdnCode>
    <emdnDescription>CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[0698L] LYFO DISK™ S. kudriavzevii ATCC 2601™</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:27:38.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>10845357016819</udiDi>
    <basicUdiDi>084535700699AX</basicUdiDi>
    <tradeName>10845357016819</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040699</emdnCode>
    <emdnDescription>CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[0699L] LYFO DISK™ S. cerevisiae ATCC 9763™</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:27:38.645Z</lastUpdated>
  </row>
  <row>
    <udiDi>10845357016888</udiDi>
    <basicUdiDi>0845357007019R</basicUdiDi>
    <tradeName>10845357016888</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040699</emdnCode>
    <emdnDescription>CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[0701L] LYFO DISK™ M. furfur ATCC 14521™</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:27:38.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>10845357017502</udiDi>
    <basicUdiDi>084535700726A9</basicUdiDi>
    <tradeName>10845357017502</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040699</emdnCode>
    <emdnDescription>CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[0726L] LYFO DISK™ C. parapsilosis ATCC 22019™</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:27:38.191Z</lastUpdated>
  </row>
  <row>
    <udiDi>10845357017595</udiDi>
    <basicUdiDi>084535700736AC</basicUdiDi>
    <tradeName>10845357017595</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040699</emdnCode>
    <emdnDescription>CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[0736L] LYFO DISK™ S. cerevisiae NCYC 79</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:27:38.066Z</lastUpdated>
  </row>
  <row>
    <udiDi>10845357017625</udiDi>
    <basicUdiDi>084535700737AE</basicUdiDi>
    <tradeName>10845357017625</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040699</emdnCode>
    <emdnDescription>CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[0737L] LYFO DISK™ C. glabrata ATCC 15126™</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:27:38.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>10845357018677</udiDi>
    <basicUdiDi>084535700774AL</basicUdiDi>
    <tradeName>10845357018677</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040699</emdnCode>
    <emdnDescription>CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[0774L] LYFO DISK™ C. lusitaniae ATCC 34449™</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:27:37.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>10845357018790</udiDi>
    <basicUdiDi>084535700778AU</basicUdiDi>
    <tradeName>10845357018790</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040699</emdnCode>
    <emdnDescription>CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[0778L] LYFO DISK™ C. dermatis ATCC 204094™</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:27:37.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>10845357018837</udiDi>
    <basicUdiDi>084535700779AW</basicUdiDi>
    <tradeName>10845357018837</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040699</emdnCode>
    <emdnDescription>CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[0779L] LYFO DISK™ C. utilis ATCC 9950™</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:27:37.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>10845357018868</udiDi>
    <basicUdiDi>084535700780AF</basicUdiDi>
    <tradeName>10845357018868</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01040699</emdnCode>
    <emdnDescription>CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[0780L] LYFO DISK™ P. wickerhamii ATCC 16529™</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:27:37.016Z</lastUpdated>
  </row>
</eudamedExport>