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<eudamedExport entity="devices">
  <row>
    <udiDi>00853615006291</udiDi>
    <basicUdiDi>0853615006MMK5E</basicUdiDi>
    <tradeName>Miscarriage Management Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>WomanCare Global, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000042625</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MMK-SU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:20:14.595Z</lastUpdated>
  </row>
  <row>
    <udiDi>00853615006314</udiDi>
    <basicUdiDi>0853615006IPASMVAPLUS8K</basicUdiDi>
    <tradeName>Ipas MVA Plus® Aspirator Accessory Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>WomanCare Global, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000042625</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AK-PLUS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:20:14.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>00853615006321</udiDi>
    <basicUdiDi>0853615006SVSNONSTERILESS</basicUdiDi>
    <tradeName>Single-Valve Aspirator Accessory Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>WomanCare Global, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000042625</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AK-SVS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:20:14.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>00853615006338</udiDi>
    <basicUdiDi>0853615006ADAPTER5B</basicUdiDi>
    <tradeName>6mm Adapter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>WomanCare Global, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000042625</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADP-6MM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:20:14.538Z</lastUpdated>
  </row>
  <row>
    <udiDi>00853615006345</udiDi>
    <basicUdiDi>0853615006ADAPTER5B</basicUdiDi>
    <tradeName>Adapter Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>WomanCare Global, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000042625</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADP-SET</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:20:14.515Z</lastUpdated>
  </row>
  <row>
    <udiDi>00853615006376</udiDi>
    <basicUdiDi>0853615006DILATORSPC</basicUdiDi>
    <tradeName>Denniston Dilators</tradeName>
    <deviceName></deviceName>
    <manufacturerName>WomanCare Global, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000042625</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DD5-S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:20:14.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>09348265003000</udiDi>
    <basicUdiDi>B-09348265003000</basicUdiDi>
    <tradeName>Geri Instrument</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genea Biomedx Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000035998</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GERI-INS-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:33.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>09348265003079</udiDi>
    <basicUdiDi>B-09348265003079</basicUdiDi>
    <tradeName>Geri Connect &amp; Assess</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genea Biomedx Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000035998</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GERI-SCA-05</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:33.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>09360350000008</udiDi>
    <basicUdiDi>B-09360350000008</basicUdiDi>
    <tradeName>PainChek</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PainChek Ltd.</manufacturerName>
    <manufacturerSrn>AU-MF-000034893</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PainChek Infant (iOS Version)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:10.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>09360350000015</udiDi>
    <basicUdiDi>B-09360350000015</basicUdiDi>
    <tradeName>PainChek</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PainChek Ltd.</manufacturerName>
    <manufacturerSrn>AU-MF-000034893</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PainChek Adult (iOS Version)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:10.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>09360350000022</udiDi>
    <basicUdiDi>B-09360350000022</basicUdiDi>
    <tradeName>PainChek</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PainChek Ltd.</manufacturerName>
    <manufacturerSrn>AU-MF-000034893</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PainChek Adult (Android Version)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:34:10.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>10850002461005</udiDi>
    <basicUdiDi>B-10850002461005</basicUdiDi>
    <tradeName>BiomarC Secure Fiducial Marker</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>040150</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T13:44:13.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>10850002461012</udiDi>
    <basicUdiDi>B-10850002461012</basicUdiDi>
    <tradeName>BiomarC Gold Fiducial Marker</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>040129</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T13:44:13.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>10850002461081</udiDi>
    <basicUdiDi>B-10850002461081</basicUdiDi>
    <tradeName>BiomarC Gold Fiducial Marker</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>040141</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T13:44:13.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>10850002461111</udiDi>
    <basicUdiDi>B-10850002461111</basicUdiDi>
    <tradeName>BiomarC EX Fiducial Marker</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>040157</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T13:44:13.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>10850002461128</udiDi>
    <basicUdiDi>B-10850002461128</basicUdiDi>
    <tradeName>BiomarC Enh Fiducial Marker</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>040158</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T13:44:13.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>10850002461135</udiDi>
    <basicUdiDi>B-10850002461135</basicUdiDi>
    <tradeName>BiomarC Enh Fiducial Marker</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>040159</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T13:44:13.174Z</lastUpdated>
  </row>
  <row>
    <udiDi>10850002461142</udiDi>
    <basicUdiDi>B-10850002461142</basicUdiDi>
    <tradeName>BiomarC EX Fiducial Marker</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>040160</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T13:44:13.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>10858015005858</udiDi>
    <basicUdiDi>B-10858015005858</basicUdiDi>
    <tradeName>BiomarC Fiducial Marker</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>040113</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T13:43:52.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>10858015005889</udiDi>
    <basicUdiDi>B-10858015005889</basicUdiDi>
    <tradeName>BiomarC Enh Fiducial Marker</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>040117</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T13:43:52.854Z</lastUpdated>
  </row>
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