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    <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>
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  <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>
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  <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>
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    <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>
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  <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>
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  <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>00840682103923</udiDi>
    <basicUdiDi>08406821BUG0051474</basicUdiDi>
    <tradeName>Giraffe Warmer</tradeName>
    <deviceName>Giraffe Warmer</deviceName>
    <manufacturerName>Datex-Ohmeda Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002206</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080407</emdnCode>
    <emdnDescription>NEONATAL RADIANT WARMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M1118179</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:02:05.872Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840682103916</udiDi>
    <basicUdiDi>08406821BUG0051576</basicUdiDi>
    <tradeName>Panda Freestanding Warmer</tradeName>
    <deviceName>Panda Freestanding Warmer</deviceName>
    <manufacturerName>Datex-Ohmeda Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002206</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080407</emdnCode>
    <emdnDescription>NEONATAL RADIANT WARMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2063568-001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:02:05.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840682103909</udiDi>
    <basicUdiDi>08406821BUG0051678</basicUdiDi>
    <tradeName>Panda Wall Mount Warmer</tradeName>
    <deviceName>Panda Wall Mount Warmer</deviceName>
    <manufacturerName>Datex-Ohmeda Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002206</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080407</emdnCode>
    <emdnDescription>NEONATAL RADIANT WARMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2063570-001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:02:01.045Z</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>
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    <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>
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    <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>
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    <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>
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    <udiDi>00814247020802</udiDi>
    <basicUdiDi>0814247001030QV</basicUdiDi>
    <tradeName>traxi Panniculus Retractor Eval Kit</tradeName>
    <deviceName>traxi Panniculus Retractor</deviceName>
    <manufacturerName>Clinical Innovations, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000031386</manufacturerSrn>
    <authorisedRepresentativeName>MVF</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011189</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080399</emdnCode>
    <emdnDescription>VARIOUS CHILDBIRTH SUPPORT AND MATERNAL ASSISTANCE INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRS-EVAL</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:18:01.178Z</lastUpdated>
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    <udiDi>00814247020628</udiDi>
    <basicUdiDi>0814247006000RP</basicUdiDi>
    <tradeName>Kiwi® Vacuum Delivery System, Omni C Cup® for Cesarean Section</tradeName>
    <deviceName>Kiwi Complete Vacuum Delivery System</deviceName>
    <manufacturerName>Clinical Innovations, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000031386</manufacturerSrn>
    <authorisedRepresentativeName>MVF</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011189</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080301</emdnCode>
    <emdnDescription>OBSTETRIC VACUUM EXTRACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VAC-6000C</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:17:59.575Z</lastUpdated>
  </row>
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    <udiDi>00814247020017</udiDi>
    <basicUdiDi>0814247700900UM</basicUdiDi>
    <tradeName>ClearView Uterine Manipulator  7cm tip</tradeName>
    <deviceName>ClearView Uterine Manipulator</deviceName>
    <manufacturerName>Clinical Innovations, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000031386</manufacturerSrn>
    <authorisedRepresentativeName>MVF</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011189</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z120899</emdnCode>
    <emdnDescription>GYNAECOLOGY AND MATERNAL-INFANTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UM700</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:17:53.978Z</lastUpdated>
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