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<eudamedExport entity="devices">
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    <udiDi>10858015005964</udiDi>
    <basicUdiDi>B-10858015005964</basicUdiDi>
    <tradeName>BiomarC EX Fiducial Marker</tradeName>
    <deviceName>BiomarC Carbon Fiducial Marker</deviceName>
    <manufacturerName>Carbon Medical Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044355</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019012</emdnCode>
    <emdnDescription>BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>040145</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:42:30.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>10858015005926</udiDi>
    <basicUdiDi>B-10858015005926</basicUdiDi>
    <tradeName>BiomarC Enh Fiducial Marker</tradeName>
    <deviceName>BiomarC Carbon Fiducial Marker</deviceName>
    <manufacturerName>Carbon Medical Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044355</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019012</emdnCode>
    <emdnDescription>BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>040135</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:42:29.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>10858015005919</udiDi>
    <basicUdiDi>B-10858015005919</basicUdiDi>
    <tradeName>BiomarC Gold Fiducial Marker</tradeName>
    <deviceName>BiomarC Gold Fiducial Marker</deviceName>
    <manufacturerName>Carbon Medical Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044355</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019012</emdnCode>
    <emdnDescription>BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>040125</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:42:28.380Z</lastUpdated>
  </row>
  <row>
    <udiDi>10858015005896</udiDi>
    <basicUdiDi>B-10858015005896</basicUdiDi>
    <tradeName>BiomarC Gold Fiducial Marker</tradeName>
    <deviceName>BiomarC Gold Fiducial Marker</deviceName>
    <manufacturerName>Carbon Medical Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044355</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019012</emdnCode>
    <emdnDescription>BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>040118</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:42:24.377Z</lastUpdated>
  </row>
  <row>
    <udiDi>10858015005889</udiDi>
    <basicUdiDi>B-10858015005889</basicUdiDi>
    <tradeName>BiomarC Enh Fiducial Marker</tradeName>
    <deviceName>BiomarC Carbon Fiducial Marker</deviceName>
    <manufacturerName>Carbon Medical Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044355</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019012</emdnCode>
    <emdnDescription>BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>040117</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:42:23.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>10858015005858</udiDi>
    <basicUdiDi>B-10858015005858</basicUdiDi>
    <tradeName>BiomarC Fiducial Marker</tradeName>
    <deviceName>BiomarC Carbon Fiducial Marker</deviceName>
    <manufacturerName>Carbon Medical Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044355</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019012</emdnCode>
    <emdnDescription>BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>040113</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:42:22.791Z</lastUpdated>
  </row>
  <row>
    <udiDi>10850002461142</udiDi>
    <basicUdiDi>B-10850002461142</basicUdiDi>
    <tradeName>BiomarC EX Fiducial Marker</tradeName>
    <deviceName>BiomarC Carbon Fiducial Marker</deviceName>
    <manufacturerName>Carbon Medical Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044355</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019012</emdnCode>
    <emdnDescription>BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>040160</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:36:20.104Z</lastUpdated>
  </row>
  <row>
    <udiDi>10850002461135</udiDi>
    <basicUdiDi>B-10850002461135</basicUdiDi>
    <tradeName>BiomarC Enh Fiducial Marker</tradeName>
    <deviceName>BiomarC Carbon Fiducial Marker</deviceName>
    <manufacturerName>Carbon Medical Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044355</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019012</emdnCode>
    <emdnDescription>BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>040159</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:36:17.698Z</lastUpdated>
  </row>
  <row>
    <udiDi>10850002461128</udiDi>
    <basicUdiDi>B-10850002461128</basicUdiDi>
    <tradeName>BiomarC Enh Fiducial Marker</tradeName>
    <deviceName>BiomarC Carbon Fiducial Marker</deviceName>
    <manufacturerName>Carbon Medical Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044355</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019012</emdnCode>
    <emdnDescription>BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>040158</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:36:16.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>10850002461111</udiDi>
    <basicUdiDi>B-10850002461111</basicUdiDi>
    <tradeName>BiomarC EX Fiducial Marker</tradeName>
    <deviceName>BiomarC Carbon Fiducial Marker</deviceName>
    <manufacturerName>Carbon Medical Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044355</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019012</emdnCode>
    <emdnDescription>BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>040157</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:36:15.301Z</lastUpdated>
  </row>
  <row>
    <udiDi>10850002461081</udiDi>
    <basicUdiDi>B-10850002461081</basicUdiDi>
    <tradeName>BiomarC Gold Fiducial Marker</tradeName>
    <deviceName>BiomarC Gold Fiducial Marker</deviceName>
    <manufacturerName>Carbon Medical Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044355</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019012</emdnCode>
    <emdnDescription>BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>040141</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:36:13.699Z</lastUpdated>
  </row>
  <row>
    <udiDi>10850002461012</udiDi>
    <basicUdiDi>B-10850002461012</basicUdiDi>
    <tradeName>BiomarC Gold Fiducial Marker</tradeName>
    <deviceName>BiomarC Gold Fiducial Marker</deviceName>
    <manufacturerName>Carbon Medical Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044355</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019012</emdnCode>
    <emdnDescription>BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>040129</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:36:11.301Z</lastUpdated>
  </row>
  <row>
    <udiDi>10850002461005</udiDi>
    <basicUdiDi>B-10850002461005</basicUdiDi>
    <tradeName>BiomarC Secure Fiducial Marker</tradeName>
    <deviceName>BiomarC Carbon Fiducial Marker</deviceName>
    <manufacturerName>Carbon Medical Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044355</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019012</emdnCode>
    <emdnDescription>BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>040150</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:36:09.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680164351143</udiDi>
    <basicUdiDi>B-08680164351143</basicUdiDi>
    <tradeName>ERS</tradeName>
    <deviceName>I-125 Seed Source</deviceName>
    <manufacturerName>Epsilon Elektronik Sanayi ve Ticaret A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000025603</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019012</emdnCode>
    <emdnDescription>BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I125S-15-9</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:12:29.749Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680164351136</udiDi>
    <basicUdiDi>B-08680164351136</basicUdiDi>
    <tradeName>ERS</tradeName>
    <deviceName>I-125 Seed Source</deviceName>
    <manufacturerName>Epsilon Elektronik Sanayi ve Ticaret A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000025603</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019012</emdnCode>
    <emdnDescription>BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I125S-15-2</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:12:28.136Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680164351129</udiDi>
    <basicUdiDi>B-08680164351129</basicUdiDi>
    <tradeName>ERS</tradeName>
    <deviceName>I-125 Seed Source</deviceName>
    <manufacturerName>Epsilon Elektronik Sanayi ve Ticaret A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000025603</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019012</emdnCode>
    <emdnDescription>BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I125S-12-9</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:12:27.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680164351112</udiDi>
    <basicUdiDi>B-08680164351112</basicUdiDi>
    <tradeName>ERS</tradeName>
    <deviceName>I-125 Seed Source</deviceName>
    <manufacturerName>Epsilon Elektronik Sanayi ve Ticaret A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000025603</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019012</emdnCode>
    <emdnDescription>BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I125S-12-2</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:12:25.736Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680164351105</udiDi>
    <basicUdiDi>B-08680164351105</basicUdiDi>
    <tradeName>ERS</tradeName>
    <deviceName>I-125 Seed Source</deviceName>
    <manufacturerName>Epsilon Elektronik Sanayi ve Ticaret A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000025603</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019012</emdnCode>
    <emdnDescription>BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I125S-10-9</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:12:23.338Z</lastUpdated>
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  <row>
    <udiDi>08680164351099</udiDi>
    <basicUdiDi>B-08680164351099</basicUdiDi>
    <tradeName>ERS</tradeName>
    <deviceName>I-125 Seed Source</deviceName>
    <manufacturerName>Epsilon Elektronik Sanayi ve Ticaret A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000025603</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019012</emdnCode>
    <emdnDescription>BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I125S-10-2</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:12:21.736Z</lastUpdated>
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  <row>
    <udiDi>08680164351082</udiDi>
    <basicUdiDi>B-08680164351082</basicUdiDi>
    <tradeName>ERS</tradeName>
    <deviceName>I-125 Seed Source</deviceName>
    <manufacturerName>Epsilon Elektronik Sanayi ve Ticaret A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000025603</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019012</emdnCode>
    <emdnDescription>BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I125S-7-9</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:12:20.972Z</lastUpdated>
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</eudamedExport>