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<eudamedExport entity="devices">
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    <udiDi>03532670501633</udiDi>
    <basicUdiDi>B-03532670501633</basicUdiDi>
    <tradeName>Contrôle Positif FOB</tradeName>
    <deviceName>FOB positive Control</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6110001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:38:23.458Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532670501602</udiDi>
    <basicUdiDi>B-03532670501602</basicUdiDi>
    <tradeName>Negative control swab</tradeName>
    <deviceName>Negative control swab</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6060001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:38:21.055Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532670103738</udiDi>
    <basicUdiDi>B-03532670103738</basicUdiDi>
    <tradeName>AMNIOQUICK Card BSX</tradeName>
    <deviceName>AMNIOQUICK CARD BSX</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060405</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1090005_BSX_C</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:38:18.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532670103714</udiDi>
    <basicUdiDi>B-03532670103714</basicUdiDi>
    <tradeName>AMNIOQUICK DUO+</tradeName>
    <deviceName>AMNIOQUICK DUO+</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160199</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1090004_C</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:38:17.065Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532670103691</udiDi>
    <basicUdiDi>B-03532670103691</basicUdiDi>
    <tradeName>AMNIOQUICK CARD</tradeName>
    <deviceName>AMNIOQUICK CARD (+ controls)</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060405</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1090005_C</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:38:14.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532670103684</udiDi>
    <basicUdiDi>B-03532670103684</basicUdiDi>
    <tradeName>AMNIOQUICK</tradeName>
    <deviceName>AMNIOQUICK</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160199</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1090003_C</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:38:13.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532670102823</udiDi>
    <basicUdiDi>B-03532670102823</basicUdiDi>
    <tradeName>Ksmart D-DIMER + Controls</tradeName>
    <deviceName>Ksmart D-DIMER + Controls</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020803</emdnCode>
    <emdnDescription>D-DIMER - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1050003_C</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:38:12.255Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532670102786</udiDi>
    <basicUdiDi>B-03532670102786</basicUdiDi>
    <tradeName>Ksmart CRP + Controls</tradeName>
    <deviceName>KSMART CRP + Controls</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160601</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1040012_C</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:38:10.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532670102755</udiDi>
    <basicUdiDi>B-03532670102755</basicUdiDi>
    <tradeName>Ksmart  CRP</tradeName>
    <deviceName>KSMART  CRP</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160601</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1040012</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:38:08.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532670102700</udiDi>
    <basicUdiDi>B-03532670102700</basicUdiDi>
    <tradeName>Ksmart D-DIMER</tradeName>
    <deviceName>KSMART D-DIMER</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020803</emdnCode>
    <emdnDescription>D-DIMER - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1050003</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:38:06.656Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532670102632</udiDi>
    <basicUdiDi>B-03532670102632</basicUdiDi>
    <tradeName>BIOSYNEX AMPLIQUICK Respiratory Duplex</tradeName>
    <deviceName>BIOSYNEX AMPLIQUICK Respiratory duplex</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3150076_SEC02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:38:05.848Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532670102625</udiDi>
    <basicUdiDi>B-03532670102625</basicUdiDi>
    <tradeName>BIOSYNEX AMPLIQUICK Respiratory Duplex</tradeName>
    <deviceName>BIOSYNEX AMPLIQUICK Respiratory duplex</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3150076_SEC01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:38:04.254Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532670101574</udiDi>
    <basicUdiDi>B-03532670101574</basicUdiDi>
    <tradeName>TETANOTOP BSX</tradeName>
    <deviceName>TETANOTOP BSX</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011709</emdnCode>
    <emdnDescription>TETANUS (CLOSTRIDIUM T.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1030016_BSX</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:38:01.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532670101567</udiDi>
    <basicUdiDi>B-03532670101567</basicUdiDi>
    <tradeName>BIOSYNEX S.pneumoniae BSX</tradeName>
    <deviceName>BIOSYNEX S. pneumoniae BSX</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090109</emdnCode>
    <emdnDescription>STREP. PNEUMONIAE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1030002_BSX</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:38:00.251Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532670100805</udiDi>
    <basicUdiDi>B-03532670100805</basicUdiDi>
    <tradeName>AMNIOQUICK Card BSX</tradeName>
    <deviceName>AMNIOQUICK CARD BSX</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060405</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1090005_BSX</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:37:55.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>03518646122248</udiDi>
    <basicUdiDi>B-03518646122248</basicUdiDi>
    <tradeName>ELLE TEST</tradeName>
    <deviceName>Elle Test</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>612224</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:36:52.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>05045098330498</udiDi>
    <basicUdiDi>B-05045098330498</basicUdiDi>
    <tradeName>Boots Vaginal Infection Self-Tests</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>83-30-492</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:06:30.619Z</lastUpdated>
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  <row>
    <udiDi>03532678606279</udiDi>
    <basicUdiDi>37603160095160125GOBGOIV6</basicUdiDi>
    <tradeName>Hydralose</tradeName>
    <deviceName>Gouttes Oculaires Hydratantes</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q02030299</emdnCode>
    <emdnDescription>OPHTHALMOLOGY, LIQUID FLUIDS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>860627</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:22:21.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532679917565</udiDi>
    <basicUdiDi>353267F00074P8G</basicUdiDi>
    <tradeName>BIOSYNEX CryptoPS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105060303</emdnCode>
    <emdnDescription>CRYPTOCOCCUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1120001-50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:27:07.529Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532679915929</udiDi>
    <basicUdiDi>353267F00189P9B</basicUdiDi>
    <tradeName>BIOSYNEX AMPLIQUICK Fecal Virology</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3150047_SEC01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:27:03.517Z</lastUpdated>
  </row>
</eudamedExport>