<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>30382904420278</udiDi>
    <basicUdiDi>038290GYRQPJVXP9</basicUdiDi>
    <tradeName>BACTEC</tradeName>
    <deviceName>BD BACTEC™ Standard/10 Aerobic/F Culture Vials</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104010504</emdnCode>
    <emdnDescription>BOTTLES FOR AUTOMATED BLOOD CULTURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>442027</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:39:50.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>G45855001008SJ</udiDi>
    <basicUdiDi>++G458550N8</basicUdiDi>
    <tradeName>Blood Culture Medium</tradeName>
    <deviceName>Blood Culture Medium</deviceName>
    <manufacturerName>Spectrum for Diagnostic Industries (Joint Stock Company)</manufacturerName>
    <manufacturerSrn>EG-MF-000033954</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104010501</emdnCode>
    <emdnDescription>BOTTLES FOR MANUAL BLOOD CULTURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>550 01 008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:06:57.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MH01997M</udiDi>
    <basicUdiDi>B-MH01997M</basicUdiDi>
    <tradeName>Hemo Aerobic Neonatal</tradeName>
    <deviceName>Hemo Aerobic Neonatal</deviceName>
    <manufacturerName>C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000010738</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104010501</emdnCode>
    <emdnDescription>BOTTLES FOR MANUAL BLOOD CULTURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MH0199</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:07:26.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MH01105JL</udiDi>
    <basicUdiDi>B-MH01105JL</basicUdiDi>
    <tradeName>Hemo One Neonatal</tradeName>
    <deviceName>Hemo One Neonatal</deviceName>
    <manufacturerName>C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000010738</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104010501</emdnCode>
    <emdnDescription>BOTTLES FOR MANUAL BLOOD CULTURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MH01105</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:07:26.429Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MH01987K</udiDi>
    <basicUdiDi>B-MH01987K</basicUdiDi>
    <tradeName>Hemo Aerobic Pediatric</tradeName>
    <deviceName>Hemo Aerobic Pediatric</deviceName>
    <manufacturerName>C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000010738</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104010501</emdnCode>
    <emdnDescription>BOTTLES FOR MANUAL BLOOD CULTURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MH0198</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:07:23.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MH01977H</udiDi>
    <basicUdiDi>B-MH01977H</basicUdiDi>
    <tradeName>Hemo Aerobic</tradeName>
    <deviceName>Hemo Aerobic</deviceName>
    <manufacturerName>C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000010738</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104010501</emdnCode>
    <emdnDescription>BOTTLES FOR MANUAL BLOOD CULTURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MH0197</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:07:22.790Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MH01104JJ</udiDi>
    <basicUdiDi>B-MH01104JJ</basicUdiDi>
    <tradeName>HEMO ONE PEDIATRIC</tradeName>
    <deviceName>HEMO ONE PEDIATRIC</deviceName>
    <manufacturerName>C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000010738</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104010501</emdnCode>
    <emdnDescription>BOTTLES FOR MANUAL BLOOD CULTURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MH01104</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:07:06.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MH01103JG</udiDi>
    <basicUdiDi>B-MH01103JG</basicUdiDi>
    <tradeName>HEMO ONE</tradeName>
    <deviceName>HEMO ONE</deviceName>
    <manufacturerName>C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000010738</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104010501</emdnCode>
    <emdnDescription>BOTTLES FOR MANUAL BLOOD CULTURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MH01103</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:07:05.861Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MH01102JE</udiDi>
    <basicUdiDi>B-MH01102JE</basicUdiDi>
    <tradeName>Hemo Anaerobic Neonatal</tradeName>
    <deviceName>Hemo Anaerobic Neonatal</deviceName>
    <manufacturerName>C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000010738</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104010501</emdnCode>
    <emdnDescription>BOTTLES FOR MANUAL BLOOD CULTURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MH01102</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:07:04.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MH01101JC</udiDi>
    <basicUdiDi>B-MH01101JC</basicUdiDi>
    <tradeName>Hemo Anaerobic Pediatric</tradeName>
    <deviceName>Hemo Anaerobic Pediatric</deviceName>
    <manufacturerName>C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000010738</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104010501</emdnCode>
    <emdnDescription>BOTTLES FOR MANUAL BLOOD CULTURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MH01101</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:07:01.808Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MH01100JA</udiDi>
    <basicUdiDi>B-MH01100JA</basicUdiDi>
    <tradeName>Hemo Anaerobic</tradeName>
    <deviceName>Hemo Anaerobic</deviceName>
    <manufacturerName>C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000010738</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104010501</emdnCode>
    <emdnDescription>BOTTLES FOR MANUAL BLOOD CULTURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MH01100</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:07:00.208Z</lastUpdated>
  </row>
  <row>
    <udiDi>08685239249394</udiDi>
    <basicUdiDi>86852392493LA1038Z</basicUdiDi>
    <tradeName>SepsiBiyo</tradeName>
    <deviceName>Lytic Anaerobic Blood Culture Bottle</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>W0104010504</emdnCode>
    <emdnDescription>BOTTLES FOR AUTOMATED BLOOD CULTURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LA 103</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:40:33.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>08685239249387</udiDi>
    <basicUdiDi>86852392493BS1069P</basicUdiDi>
    <tradeName>SepsiBiyo</tradeName>
    <deviceName>Brucella Blood Culture Bottle</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>W0104010504</emdnCode>
    <emdnDescription>BOTTLES FOR AUTOMATED BLOOD CULTURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BS 106</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:40:33.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>08685239249370</udiDi>
    <basicUdiDi>86852392493ML105BV</basicUdiDi>
    <tradeName>SepsiBiyo</tradeName>
    <deviceName>Myco/F Lytic Blood Culture Bottle</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>W0104010504</emdnCode>
    <emdnDescription>BOTTLES FOR AUTOMATED BLOOD CULTURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ML 105</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:40:32.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>08685239249363</udiDi>
    <basicUdiDi>86852392493TB104C2</basicUdiDi>
    <tradeName>SepsiBiyo</tradeName>
    <deviceName>Mycobacteria Blood Culture Bottle</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>W0104010504</emdnCode>
    <emdnDescription>BOTTLES FOR AUTOMATED BLOOD CULTURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB 104</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:40:28.293Z</lastUpdated>
  </row>
  <row>
    <udiDi>08685239249325</udiDi>
    <basicUdiDi>86852392493SB102BK</basicUdiDi>
    <tradeName>SepsiBiyo</tradeName>
    <deviceName>Pediatric Aerobic Blood Culture Bottle</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>W0104010504</emdnCode>
    <emdnDescription>BOTTLES FOR AUTOMATED BLOOD CULTURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SB 102</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:40:21.886Z</lastUpdated>
  </row>
  <row>
    <udiDi>08685239249318</udiDi>
    <basicUdiDi>86852392493SB101BH</basicUdiDi>
    <tradeName>SepsiBiyo</tradeName>
    <deviceName>Anaerobic Blood Culture Bottle</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>W0104010504</emdnCode>
    <emdnDescription>BOTTLES FOR AUTOMATED BLOOD CULTURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SB 101</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:40:21.180Z</lastUpdated>
  </row>
  <row>
    <udiDi>08685239249301</udiDi>
    <basicUdiDi>86852392493SB100BF</basicUdiDi>
    <tradeName>SepsiBiyo</tradeName>
    <deviceName>Aerobic Blood Culture Bottle</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>W0104010504</emdnCode>
    <emdnDescription>BOTTLES FOR AUTOMATED BLOOD CULTURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SB 100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:40:20.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684298125595</udiDi>
    <basicUdiDi>86842981255LA1079N</basicUdiDi>
    <tradeName>Lytic Anaerobic Blood Culture Bottle</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0104010504</emdnCode>
    <emdnDescription>BOTTLES FOR AUTOMATED BLOOD CULTURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LA107</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:23:43.409Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684298125533</udiDi>
    <basicUdiDi>86842981255TB104CF</basicUdiDi>
    <tradeName>SepsiBiyo</tradeName>
    <deviceName>Tuberculosis Blood Culture Bottle</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>W0104010504</emdnCode>
    <emdnDescription>BOTTLES FOR AUTOMATED BLOOD CULTURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB104</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:23:35.412Z</lastUpdated>
  </row>
</eudamedExport>