<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06938010902820</udiDi>
    <basicUdiDi>69380109028205G</basicUdiDi>
    <tradeName>06938010902820</tradeName>
    <deviceName>Bacterial McFarland Standard</deviceName>
    <manufacturerName>Hunan Mindray Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022479</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</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>105-058930-00</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:05:54.408Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938010901762</udiDi>
    <basicUdiDi>69380109017625L</basicUdiDi>
    <tradeName>06938010901762</tradeName>
    <deviceName>Bacterial McFarland Standard</deviceName>
    <manufacturerName>Hunan Mindray Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022479</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</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>TDR-Z2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:05:48.516Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251204325000</udiDi>
    <basicUdiDi>425120430500001000HB</basicUdiDi>
    <tradeName>IVD Bacterical Test Standard</tradeName>
    <deviceName>IVD Bacterical Test Standard</deviceName>
    <manufacturerName>Bruker Daltonics GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000024392</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>8290190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:53:20.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026551155</udiDi>
    <basicUdiDi>357302BUDI000503T9</basicUdiDi>
    <tradeName>DensiCHEK™ CALIBRATION STANDARD</tradeName>
    <deviceName>DensiCHEK™ CALIBRATION STANDARD</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</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>8309072</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:53:05.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026040949</udiDi>
    <basicUdiDi>357302BUDI000212ST</basicUdiDi>
    <tradeName>ATB™ DENSITOMETER CONTROL KIT</tradeName>
    <deviceName>ATB™ DENSITOMETER CONTROL KIT</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>15512</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:47:35.342Z</lastUpdated>
  </row>
  <row>
    <udiDi>10845357013061</udiDi>
    <basicUdiDi>084535700537A4</basicUdiDi>
    <tradeName>10845357013061</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>[0537U] KWIK-STIK™ C. cladosporioides ATCC 16022™</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:13:12.669Z</lastUpdated>
  </row>
  <row>
    <udiDi>10845357012972</udiDi>
    <basicUdiDi>0845357005349W</basicUdiDi>
    <tradeName>10845357012972</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>[0534U] KWIK-STIK™ S. cerevisiae ATCC 4098™</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:13:11.851Z</lastUpdated>
  </row>
  <row>
    <udiDi>10845357012873</udiDi>
    <basicUdiDi>0845357005319Q</basicUdiDi>
    <tradeName>10845357012873</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>[0531U] KWIK-STIK™ F. keratoplasticum ATCC 36031™</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:13:07.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>10845357012606</udiDi>
    <basicUdiDi>0845357005209K</basicUdiDi>
    <tradeName>10845357012606</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>[0520U] KWIK-STIK™ C. geochares ATCC 36852™</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:12:59.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>10845357012576</udiDi>
    <basicUdiDi>084535700519A2</basicUdiDi>
    <tradeName>10845357012576</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>[0519U] KWIK-STIK™ G. candidus ATCC 34614™</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:12:59.048Z</lastUpdated>
  </row>
  <row>
    <udiDi>10845357012309</udiDi>
    <basicUdiDi>0845357005109G</basicUdiDi>
    <tradeName>10845357012309</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>[0510U] KWIK-STIK™ C. krusei ATCC 34135™</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:12:53.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>10845357012026</udiDi>
    <basicUdiDi>0845357005009D</basicUdiDi>
    <tradeName>10845357012026</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>[0500U] KWIK-STIK™ A. niger ATCC 6275™</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:12:30.170Z</lastUpdated>
  </row>
  <row>
    <udiDi>10845357010497</udiDi>
    <basicUdiDi>0845357004509P</basicUdiDi>
    <tradeName>10845357010497</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>[0450U] KWIK-STIK™ C. tropicalis ATCC 13803™</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:11:29.284Z</lastUpdated>
  </row>
  <row>
    <udiDi>10845357010350</udiDi>
    <basicUdiDi>0845357004449U</basicUdiDi>
    <tradeName>10845357010350</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>[0444U] KWIK-STIK™ T. rubrum ATCC 28188™</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:11:22.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>10845357010299</udiDi>
    <basicUdiDi>0845357004439S</basicUdiDi>
    <tradeName>10845357010299</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>[0443U] KWIK-STIK™ C. albicans ATCC 10231™</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:11:22.073Z</lastUpdated>
  </row>
  <row>
    <udiDi>10845357010237</udiDi>
    <basicUdiDi>0845357004429Q</basicUdiDi>
    <tradeName>10845357010237</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>[0442U] KWIK-STIK™ T. interdigitale ATCC 9533™</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:11:18.078Z</lastUpdated>
  </row>
  <row>
    <udiDi>10845357009781</udiDi>
    <basicUdiDi>0845357004259Q</basicUdiDi>
    <tradeName>10845357009781</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>[0425U] KWIK-STIK™ C. albicans ATCC 60193™</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:11:02.881Z</lastUpdated>
  </row>
  <row>
    <udiDi>10845357003628</udiDi>
    <basicUdiDi>0845357002279J</basicUdiDi>
    <tradeName>10845357003628</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>[0227U] KWIK-STIK™ I. orientalis ATCC 6258™</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:10:21.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026100087</udiDi>
    <basicUdiDi>357302BUDI000502T7</basicUdiDi>
    <tradeName>McFarland Standard</tradeName>
    <deviceName>McFarland Standard</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>70900</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:50:20.228Z</lastUpdated>
  </row>
  <row>
    <udiDi>84352873209250</udiDi>
    <basicUdiDi>B-84352873209250</basicUdiDi>
    <tradeName>Cromatest</tradeName>
    <deviceName>RPR-VDRL-TPHA negative control</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01040699</emdnCode>
    <emdnDescription>CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2925805</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:32:53.189Z</lastUpdated>
  </row>
</eudamedExport>