<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08809892190026</udiDi>
    <basicUdiDi>880989219MMSEVC</basicUdiDi>
    <tradeName>IDSys Elite</tradeName>
    <deviceName>IDSys Elite</deviceName>
    <manufacturerName>ASTA Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000051737</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02030199</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MMS-EB-03</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:03:14.041Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800317990009</udiDi>
    <basicUdiDi>880031799IP01DY</basicUdiDi>
    <tradeName>I-PREP2</tradeName>
    <deviceName>I-PREP LBC Processor</deviceName>
    <manufacturerName>Imedikers Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000047937</manufacturerSrn>
    <authorisedRepresentativeName>Veritas Eston OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000046695</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02039004</emdnCode>
    <emdnDescription>AUTOMATED SLIDE PREPARATION UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Liquid Based Cytology System I-PREP USER MANUAL Ver.01</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:37:17.871Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800044300034</udiDi>
    <basicUdiDi>88000443dRASTT8</basicUdiDi>
    <tradeName>dRAST</tradeName>
    <deviceName>dRAST</deviceName>
    <manufacturerName>QuantaMatrix Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022784</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0203010180</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QMdRASTR02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:24:34.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>08685239249356</udiDi>
    <basicUdiDi>86852392493SB240BY</basicUdiDi>
    <tradeName>SepsiBiyo</tradeName>
    <deviceName>Fully Automatic Blood Culture Machine - Integrated</deviceName>
    <manufacturerName>BİYOFEN KURUMSAL SAĞLIK HİZMETLERİ YAZILIM TURİZM SANAYİ TİCARET LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000054086</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02030201</emdnCode>
    <emdnDescription>AUTOMATED BLOOD CULTURE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SB 240</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:40:27.488Z</lastUpdated>
  </row>
  <row>
    <udiDi>08685239249349</udiDi>
    <basicUdiDi>86852392493SB120BM</basicUdiDi>
    <tradeName>SepsiBiyo</tradeName>
    <deviceName>Fully Automatic Blood Culture Machine - Integrated</deviceName>
    <manufacturerName>BİYOFEN KURUMSAL SAĞLIK HİZMETLERİ YAZILIM TURİZM SANAYİ TİCARET LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000054086</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02030201</emdnCode>
    <emdnDescription>AUTOMATED BLOOD CULTURE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SB 120</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:40:26.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>08685239249332</udiDi>
    <basicUdiDi>86852392493SB609G</basicUdiDi>
    <tradeName>SepsiBiyo</tradeName>
    <deviceName>Fully Automatic Blood Culture Machine - Integrated</deviceName>
    <manufacturerName>BİYOFEN KURUMSAL SAĞLIK HİZMETLERİ YAZILIM TURİZM SANAYİ TİCARET LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000054086</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02030201</emdnCode>
    <emdnDescription>AUTOMATED BLOOD CULTURE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SB 60</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:40:25.892Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684298125564</udiDi>
    <basicUdiDi>86842981255SB120C2</basicUdiDi>
    <tradeName>SepsiBiyo</tradeName>
    <deviceName>Automatic Blood Culture System</deviceName>
    <manufacturerName>HOSMED GRUP MEDİKAL SAĞLIK HİZMETLERİ LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000054148</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02030201</emdnCode>
    <emdnDescription>AUTOMATED BLOOD CULTURE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SB120</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:23:41.016Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681677201482</udiDi>
    <basicUdiDi>86816772MTK8Z</basicUdiDi>
    <tradeName>MYCOLOR TK 336</tradeName>
    <deviceName>Automated Computerized Incubator-Reader Device</deviceName>
    <manufacturerName>Innovative Biotechnology Organization Trade Limited Company</manufacturerName>
    <manufacturerSrn>TR-MF-000037634</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02030299</emdnCode>
    <emdnDescription>INSTRUMENTS FOR BLOOD CULTURES AND MYCOBACTERIA - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTK336</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:33:19.502Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437024289005</udiDi>
    <basicUdiDi>8437024289Autoplak01BG</basicUdiDi>
    <tradeName>08437024289005</tradeName>
    <deviceName>Autoplak</deviceName>
    <manufacturerName>SENER Diagnostics S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000030726</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020305</emdnCode>
    <emdnDescription>PLATES STREAKING EQUIPMENT (STREAKER/ INCUBATOR/ READER)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Autoplak Complete</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:13:21.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>58059796360857</udiDi>
    <basicUdiDi>805014821IP250CMDSWM02ZA</basicUdiDi>
    <tradeName>PhenoMATRIX</tradeName>
    <deviceName>PhenoMATRIX</deviceName>
    <manufacturerName>Copan Wasp S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000012489</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02039092</emdnCode>
    <emdnDescription>VARIOUS MICROBIOLOGY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WLAB-PHENOMATRIX</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:36:41.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>58059796360840</udiDi>
    <basicUdiDi>805014821IP060CMDSWM02Y9</basicUdiDi>
    <tradeName>Radian Expert System</tradeName>
    <deviceName>Radian Expert System</deviceName>
    <manufacturerName>Copan Wasp S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000012489</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0203010192</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WLAB-RADIAN</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:36:40.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>58052870815366</udiDi>
    <basicUdiDi>805014821IP050BMDSWM02WR</basicUdiDi>
    <tradeName>SOFTWARE HALO MEASURE &amp; VISUAL</tradeName>
    <deviceName>SOFTWARE HALO MEASURE &amp; VISUAL</deviceName>
    <manufacturerName>Copan Wasp S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000012489</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0203010192</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WLAB-SW-HALO</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:36:39.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>58050148218208</udiDi>
    <basicUdiDi>805014821IP080AAUTOM01XX</basicUdiDi>
    <tradeName>Colibrí</tradeName>
    <deviceName>Colibrí System</deviceName>
    <manufacturerName>Copan Wasp S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000012489</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02030199</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W090</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:36:33.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>58050148211438</udiDi>
    <basicUdiDi>805014821IP040AAUTOM01UB</basicUdiDi>
    <tradeName>WASPLab Single Incubator</tradeName>
    <deviceName>WASPLab System</deviceName>
    <manufacturerName>Copan Wasp S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000012489</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02039099</emdnCode>
    <emdnDescription>VARIOUS MICROBIOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>W087-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:36:32.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>18050148217968</udiDi>
    <basicUdiDi>805014821IP210ATUBEM04VF</basicUdiDi>
    <tradeName>Colibrì PRIMARY TUBE FOR VITEK 2</tradeName>
    <deviceName>Primary Tubes</deviceName>
    <manufacturerName>Copan Wasp S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000012489</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WR090-01-0002</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:35:18.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>18050148216732</udiDi>
    <basicUdiDi>805014821IP190ATUBEM043T</basicUdiDi>
    <tradeName>PBS solution 2ml</tradeName>
    <deviceName>PBS Solution</deviceName>
    <manufacturerName>Copan Wasp S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000012489</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WR086-03-1015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:35:17.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>18050148212864</udiDi>
    <basicUdiDi>805014821IP150ALOOPM03Y8</basicUdiDi>
    <tradeName>Colibrì SPREADER</tradeName>
    <deviceName>Spreader for purity plate</deviceName>
    <manufacturerName>Copan Wasp S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000012489</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WR090-01-0605T</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:35:16.248Z</lastUpdated>
  </row>
  <row>
    <udiDi>08050148218005</udiDi>
    <basicUdiDi>805014821IP230ATUBEM04X9</basicUdiDi>
    <tradeName>Colibrì DAILY VERIFICATION KIT</tradeName>
    <deviceName>Verification</deviceName>
    <manufacturerName>Copan Wasp S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000012489</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WR090-01-0004</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:32:04.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>08050054301228</udiDi>
    <basicUdiDi>805005430STR019A9P</basicUdiDi>
    <tradeName>SaCycler-96R Real Time PCR System</tradeName>
    <deviceName>SaCycler-96R Real Time PCR System</deviceName>
    <manufacturerName>Sacace Biotechnologies S.r.l</manufacturerName>
    <manufacturerSrn>IT-MF-000031072</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02039006</emdnCode>
    <emdnDescription>DNA THERMAL CYCLERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC-96R</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:32:02.377Z</lastUpdated>
  </row>
  <row>
    <udiDi>08050148211396</udiDi>
    <basicUdiDi>805014821IP020AAUTOM01SH</basicUdiDi>
    <tradeName>Basic AST System</tradeName>
    <deviceName>WASP System</deviceName>
    <manufacturerName>Copan Wasp S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000012489</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0203010180</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WO086-80-2000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:32:01.572Z</lastUpdated>
  </row>
</eudamedExport>