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<eudamedExport entity="devices">
  <row>
    <udiDi>03760415600024</udiDi>
    <basicUdiDi>376041560FESMD01BC</basicUdiDi>
    <tradeName>B-Right Screen Fetal Heart</tradeName>
    <deviceName>Fetal EchoScan (B-Right Screen Fetal Heart)</deviceName>
    <manufacturerName>BrightHeart</manufacturerName>
    <manufacturerSrn>FR-MF-000044855</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080192</emdnCode>
    <emdnDescription>PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FESMD01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:04:48.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>00888937025767</udiDi>
    <basicUdiDi>0888937TD070ZQ</basicUdiDi>
    <tradeName>TransWarmer®</tradeName>
    <deviceName>WarmGel® Infant Heel Warmer with Lift and Stick Tape</deviceName>
    <manufacturerName>CooperSurgical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002607</manufacturerSrn>
    <authorisedRepresentativeName>CooperSurgical Distribution B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000059</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080407</emdnCode>
    <emdnDescription>NEONATAL RADIANT WARMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20421</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:43:36.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>00888937003048</udiDi>
    <basicUdiDi>0888937TD07627</basicUdiDi>
    <tradeName>Mityvac® M-Style® Mushroom® Cup</tradeName>
    <deviceName>Mityvac® M-Style® Mushroom® Cup Vacuum-Assist Delivery System</deviceName>
    <manufacturerName>CooperSurgical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002607</manufacturerSrn>
    <authorisedRepresentativeName>CooperSurgical Distribution B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000059</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080301</emdnCode>
    <emdnDescription>OBSTETRIC VACUUM EXTRACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10007LP</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:43:01.389Z</lastUpdated>
  </row>
  <row>
    <udiDi>30884838051752</udiDi>
    <basicUdiDi>0884838BM776TW</basicUdiDi>
    <tradeName>BILECLIPSE, 50 PACK</tradeName>
    <deviceName>BilEclipse Phototherapy Protective Patch</deviceName>
    <manufacturerName>Philips Medical Systems</manufacturerName>
    <manufacturerSrn>US-MF-000002321</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080410</emdnCode>
    <emdnDescription>TRANSCUTANEOUS BILIRUBINOMETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>B800-11</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:26:51.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>30884838011763</udiDi>
    <basicUdiDi>0884838BM575TJ</basicUdiDi>
    <tradeName>Fetal monitoring recording paper</tradeName>
    <deviceName>Fetal Monitor Recorder Paper</deviceName>
    <manufacturerName>Philips Medizin Systeme Böblingen GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080180</emdnCode>
    <emdnDescription>PRENATAL DIAGNOSTIC INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>989803105491</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:26:51.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>20884838007493</udiDi>
    <basicUdiDi>0884838BM530SU</basicUdiDi>
    <tradeName>ATTACHMENT ELECTRODE</tradeName>
    <deviceName>Attachment Electrode</deviceName>
    <manufacturerName>Philips Medical Systems</manufacturerName>
    <manufacturerSrn>US-MF-000002321</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>989803139771</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:26:46.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838010338</udiDi>
    <basicUdiDi>0884838BM585TM</basicUdiDi>
    <tradeName>MECG Adapter Cable</tradeName>
    <deviceName>MECG Adapter Cable</deviceName>
    <manufacturerName>Philips Medizin Systeme Böblingen GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1208010499</emdnCode>
    <emdnDescription>CARDIOTOCOGRAPHIC TELEMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>989803103561</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:18:32.659Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838009950</udiDi>
    <basicUdiDi>0884838BM599TY</basicUdiDi>
    <tradeName>Remote Event Marker</tradeName>
    <deviceName>Remote Event Marker</deviceName>
    <manufacturerName>Philips Medizin Systeme Böblingen GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1208010499</emdnCode>
    <emdnDescription>CARDIOTOCOGRAPHIC TELEMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>989803143411</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:18:31.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838007451</udiDi>
    <basicUdiDi>0884838BM529TB</basicUdiDi>
    <tradeName>DECG REUSABLE LEGPLATE ADAPTER PHILIPS</tradeName>
    <deviceName>DECG Legplate Adapter Cable</deviceName>
    <manufacturerName>Philips Medical Systems</manufacturerName>
    <manufacturerSrn>US-MF-000002321</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>989803137651</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:18:27.054Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838116498</udiDi>
    <basicUdiDi>0884838BM1631MJ</basicUdiDi>
    <tradeName>REUSABLE LEG BELT- 32MM X 15M</tradeName>
    <deviceName>Disposable and reusable fetal belts</deviceName>
    <manufacturerName>Philips Medizin Systeme Böblingen GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M4601A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:12:35.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838096578</udiDi>
    <basicUdiDi>0884838BM341SP</basicUdiDi>
    <tradeName>Bilical, 50 Pack</tradeName>
    <deviceName>BiliCal Tips</deviceName>
    <manufacturerName>Philips Medical Systems</manufacturerName>
    <manufacturerSrn>US-MF-000002321</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080410</emdnCode>
    <emdnDescription>TRANSCUTANEOUS BILIRUBINOMETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>B800-50</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:11:31.829Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838009424</udiDi>
    <basicUdiDi>0884838BM337SY</basicUdiDi>
    <tradeName>REUSABLE LEG BELT- 32MM X 15M</tradeName>
    <deviceName>Disposable and reusable fetal belts</deviceName>
    <manufacturerName>Philips Medical Systems</manufacturerName>
    <manufacturerSrn>US-MF-000002321</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M4601A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:10:08.904Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720892749406</udiDi>
    <basicUdiDi>08720892App-06-V1.0PE</basicUdiDi>
    <tradeName>Danae App</tradeName>
    <deviceName>Danae App</deviceName>
    <manufacturerName>Danae Netherlands BV</manufacturerName>
    <manufacturerSrn>NL-MF-000048363</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>Danae App 2025-06</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:05:02.945Z</lastUpdated>
  </row>
  <row>
    <udiDi>00860008987204</udiDi>
    <basicUdiDi>08600089872HERARB</basicUdiDi>
    <tradeName>Embryo Predict</tradeName>
    <deviceName>Embryo Predict</deviceName>
    <manufacturerName>Alife Health Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000028240</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080292</emdnCode>
    <emdnDescription>GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200-00201</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:52:47.145Z</lastUpdated>
  </row>
  <row>
    <udiDi>10853615006366</udiDi>
    <basicUdiDi>0853615006DVSSTERILELH</basicUdiDi>
    <tradeName>Double Valve Aspirator</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-S10</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:46:23.680Z</lastUpdated>
  </row>
  <row>
    <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>
</eudamedExport>