<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>
  <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>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>
  </row>
  <row>
    <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>
  <row>
    <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>
  </row>
  <row>
    <udiDi>10812432022485</udiDi>
    <basicUdiDi>081243202MD078QM</basicUdiDi>
    <tradeName>10812432022485</tradeName>
    <deviceName>BiliSoft Large Pad Nests, Box of 15</deviceName>
    <manufacturerName>Lumitex Medical Devices, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000030520</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080499</emdnCode>
    <emdnDescription>NEONATOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2105423-001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:13:44.049Z</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>00810101280498</udiDi>
    <basicUdiDi>0810101280203JJ</basicUdiDi>
    <tradeName>bili-ruler</tradeName>
    <deviceName>bili-ruler</deviceName>
    <manufacturerName>Little Sparrows Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000040265</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080499</emdnCode>
    <emdnDescription>NEONATOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0203A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:53:23.785Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810101280450</udiDi>
    <basicUdiDi>0810101280108JP</basicUdiDi>
    <tradeName>00810101280450</tradeName>
    <deviceName>bili-hut perch</deviceName>
    <manufacturerName>Little Sparrows Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000040265</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0108A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:53:22.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810101280436</udiDi>
    <basicUdiDi>0810101280133JN</basicUdiDi>
    <tradeName>00810101280436</tradeName>
    <deviceName>bili-hut nest and mattress consumables</deviceName>
    <manufacturerName>Little Sparrows Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000040265</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0133ADL5</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:53:22.186Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810101280405</udiDi>
    <basicUdiDi>0810101280130JG</basicUdiDi>
    <tradeName>bili-hut</tradeName>
    <deviceName>bili-hut</deviceName>
    <manufacturerName>Little Sparrows Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000040265</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0130A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:53:18.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>07612367089388</udiDi>
    <basicUdiDi>07612367maxjyzP4</basicUdiDi>
    <tradeName>07612367089388</tradeName>
    <deviceName>Hands-free Breat Shields</deviceName>
    <manufacturerName>Medela AG</manufacturerName>
    <manufacturerSrn>CH-MF-000018913</manufacturerSrn>
    <authorisedRepresentativeName>Medela Medizintechnik GmbH &amp; Co. Handels KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008746</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080399</emdnCode>
    <emdnDescription>VARIOUS CHILDBIRTH SUPPORT AND MATERNAL ASSISTANCE INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101047308</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:10:24.621Z</lastUpdated>
  </row>
</eudamedExport>