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<eudamedExport entity="devices">
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    <udiDi>10853615006359</udiDi>
    <basicUdiDi>0853615006SVSSTERILE27</basicUdiDi>
    <tradeName>Single Valve Aspirator</tradeName>
    <deviceName>SINGLE-VALVE ASPIRATOR</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>MDR 2017/745</legislation>
    <emdnCode>Z12080299</emdnCode>
    <emdnDescription>GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SVS-S10</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:46:19.683Z</lastUpdated>
  </row>
  <row>
    <udiDi>00853615006376</udiDi>
    <basicUdiDi>0853615006DILATORSPC</basicUdiDi>
    <tradeName>Denniston Dilators</tradeName>
    <deviceName>DENNISTON DILATORS</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>MDR 2017/745</legislation>
    <emdnCode>Z12080299</emdnCode>
    <emdnDescription>GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DD5-S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:39:18.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>00853615006338</udiDi>
    <basicUdiDi>0853615006ADAPTER5B</basicUdiDi>
    <tradeName>6mm Adapter</tradeName>
    <deviceName>ADAPTER SET</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>MDR 2017/745</legislation>
    <emdnCode>Z12080299</emdnCode>
    <emdnDescription>GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADP-6MM</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:39:17.367Z</lastUpdated>
  </row>
  <row>
    <udiDi>00853615006291</udiDi>
    <basicUdiDi>0853615006MMK5E</basicUdiDi>
    <tradeName>Miscarriage Management Kit</tradeName>
    <deviceName>MISCARRIAGE MANAGEMENT KIT</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>MDR 2017/745</legislation>
    <emdnCode>Z12080299</emdnCode>
    <emdnDescription>GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MMK-SU</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:39:15.768Z</lastUpdated>
  </row>
  <row>
    <udiDi>00853615006284</udiDi>
    <basicUdiDi>08536150063MMZJ</basicUdiDi>
    <tradeName>3mm Cannula</tradeName>
    <deviceName>3MM CANNULAE</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>MDR 2017/745</legislation>
    <emdnCode>Z12080299</emdnCode>
    <emdnDescription>GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EB3</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:39:13.367Z</lastUpdated>
  </row>
  <row>
    <udiDi>00853615006277</udiDi>
    <basicUdiDi>0853615006SVSNONSTERILESS</basicUdiDi>
    <tradeName>Single Valve Aspirator</tradeName>
    <deviceName>SINGLE-VALVE ASPIRATOR</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>MDR 2017/745</legislation>
    <emdnCode>Z12080299</emdnCode>
    <emdnDescription>GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SVS-LF</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:39:11.764Z</lastUpdated>
  </row>
  <row>
    <udiDi>00853615006260</udiDi>
    <basicUdiDi>0853615006IPASMVAPLUS8K</basicUdiDi>
    <tradeName>Ipas MVA Plus® Aspirator</tradeName>
    <deviceName>IPAS MVA PLUS® ASPIRATOR</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>MDR 2017/745</legislation>
    <emdnCode>Z12080299</emdnCode>
    <emdnDescription>GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PLUS</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:39:10.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>00853615006253</udiDi>
    <basicUdiDi>0853615006DVSNONSTERILE7K</basicUdiDi>
    <tradeName>Double Valve Aspirator, unsterile</tradeName>
    <deviceName>DOUBLE-VALVE ASPIRATOR</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>MDR 2017/745</legislation>
    <emdnCode>Z12080299</emdnCode>
    <emdnDescription>GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DVS-SU</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:39:09.358Z</lastUpdated>
  </row>
  <row>
    <udiDi>00853615006093</udiDi>
    <basicUdiDi>0853615006EASYGRIPTD</basicUdiDi>
    <tradeName>Ipas EasyGrip® Cannula, size 10mm</tradeName>
    <deviceName>IPAS EASYGRIP® CANNULA</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>MDR 2017/745</legislation>
    <emdnCode>Z12080299</emdnCode>
    <emdnDescription>GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR10</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:39:06.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>00853615006000</udiDi>
    <basicUdiDi>0853615006FLEXIBLERB</basicUdiDi>
    <tradeName>Flexible Karman Cannula, size 10mm</tradeName>
    <deviceName>FLEXIBLE KARMAN CANNULA</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>MDR 2017/745</legislation>
    <emdnCode>Z12080299</emdnCode>
    <emdnDescription>GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FC10</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:39:04.559Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850008595042</udiDi>
    <basicUdiDi>0850008595ECBZF</basicUdiDi>
    <tradeName>Exhaust Collection Bag</tradeName>
    <deviceName>Exhaust Collection Bag</deviceName>
    <manufacturerName>Channel Medsystems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000028229</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080201</emdnCode>
    <emdnDescription>ENDOMETRIAL ABLATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FGS-7015</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:09:51.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850008595035</udiDi>
    <basicUdiDi>0850008595CCDZ9</basicUdiDi>
    <tradeName>Cerene Cryotherapy Device</tradeName>
    <deviceName>Cerene Cryotherapy Device</deviceName>
    <manufacturerName>Channel Medsystems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000028229</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080201</emdnCode>
    <emdnDescription>ENDOMETRIAL ABLATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FGS-7000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:09:51.098Z</lastUpdated>
  </row>
  <row>
    <udiDi>30817929020177</udiDi>
    <basicUdiDi>081792902RFACBLC9</basicUdiDi>
    <tradeName>Sonata RFA Cable, reusable</tradeName>
    <deviceName>Sonata RFA Cable, reusable</deviceName>
    <manufacturerName>Gynesonics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017044</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080280</emdnCode>
    <emdnDescription>GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACCY-008</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:35:00.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>10817929020463</udiDi>
    <basicUdiDi>081792902IUSPCCK9</basicUdiDi>
    <tradeName>Sonata IUUS Probe Connector Protector</tradeName>
    <deviceName>Sonata IUUS Probe Connector Protector</deviceName>
    <manufacturerName>Gynesonics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017044</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080280</emdnCode>
    <emdnDescription>GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACCY-018</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:34:58.855Z</lastUpdated>
  </row>
  <row>
    <udiDi>10817929020371</udiDi>
    <basicUdiDi>081792902RFAHPD5</basicUdiDi>
    <tradeName>Sonata Radiofrequency Ablation Handpiece</tradeName>
    <deviceName>Sonata Radiofrequency Ablation Handpiece</deviceName>
    <manufacturerName>Gynesonics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017044</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080299</emdnCode>
    <emdnDescription>GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RFA-002</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:34:54.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>10817929020364</udiDi>
    <basicUdiDi>081792902RFDEEB</basicUdiDi>
    <tradeName>Sonata Dispersive Electrode</tradeName>
    <deviceName>Sonata Dispersive Electrode</deviceName>
    <manufacturerName>Gynesonics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017044</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080299</emdnCode>
    <emdnDescription>GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DE-001</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:34:54.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>10817929020333</udiDi>
    <basicUdiDi>081792902SONATAKA</basicUdiDi>
    <tradeName>Sonata® Transcervical Fibroid Ablation System</tradeName>
    <deviceName>Sonata® Transcervical Fibroid Ablation System</deviceName>
    <manufacturerName>Gynesonics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017044</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080299</emdnCode>
    <emdnDescription>GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SONATA2-220</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:34:53.226Z</lastUpdated>
  </row>
  <row>
    <udiDi>10817929020036</udiDi>
    <basicUdiDi>081792902RTNKITNB</basicUdiDi>
    <tradeName>Sonata IUUS Probe Return Kit</tradeName>
    <deviceName>Sonata IUUS Probe Return Kit</deviceName>
    <manufacturerName>Gynesonics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017044</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080280</emdnCode>
    <emdnDescription>GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTN-001</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:34:47.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812261016535</udiDi>
    <basicUdiDi>081226101OPN058UV</basicUdiDi>
    <tradeName>OVUMPICK Ovum Pickup Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Allwin Medical Devices, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000011349</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080202</emdnCode>
    <emdnDescription>OOCYTE ASPIRATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OVM-DL16/35</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:11:50.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>00194253312512</udiDi>
    <basicUdiDi>0194253CycleTracking44C</basicUdiDi>
    <tradeName>00194253312512</tradeName>
    <deviceName>Cycle Tracking App</deviceName>
    <manufacturerName>Apple Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013709</manufacturerSrn>
    <authorisedRepresentativeName>Apple Distribution International Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000012406</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080282</emdnCode>
    <emdnDescription>GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Cycle Tracking App 4.X</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:03:34.168Z</lastUpdated>
  </row>
</eudamedExport>