<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05060433670091</udiDi>
    <basicUdiDi>8406821BUG00136H6</basicUdiDi>
    <tradeName>NOVII INTERFACE CABLE - GE FECG</tradeName>
    <deviceName>NOVII INTERFACE CABLE</deviceName>
    <manufacturerName>Datex-Ohmeda Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002206</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1208010480</emdnCode>
    <emdnDescription>CARDIOTOCOGRAPHIC TELEMETRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-PT-102</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:20:53.950Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903641127943</udiDi>
    <basicUdiDi>59036411279PREGNABITCLR9</basicUdiDi>
    <tradeName>Pregnabit Cloud</tradeName>
    <deviceName>Pregnabit Cloud</deviceName>
    <manufacturerName>Nestmedic S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002204</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1208010401</emdnCode>
    <emdnDescription>COMPLETE CARDIOTOCOGRAPHIC TELEMETRY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00002</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:06:19.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>05903641127929</udiDi>
    <basicUdiDi>59036411279PREGNABITPROYA</basicUdiDi>
    <tradeName>Pregnabit Pro</tradeName>
    <deviceName>Pregnabit Pro</deviceName>
    <manufacturerName>Nestmedic S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002204</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1208010401</emdnCode>
    <emdnDescription>COMPLETE CARDIOTOCOGRAPHIC TELEMETRY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00001</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:06:18.325Z</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>00884838093225</udiDi>
    <basicUdiDi>B-00884838093225</basicUdiDi>
    <tradeName>Avalon Toco+ Transducer</tradeName>
    <deviceName>Avalon Toco+ Transducer</deviceName>
    <manufacturerName>Philips Medizin Systeme Böblingen GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1208010499</emdnCode>
    <emdnDescription>CARDIOTOCOGRAPHIC TELEMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>867249</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:08:53.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838093218</udiDi>
    <basicUdiDi>B-00884838093218</basicUdiDi>
    <tradeName>Avalon Toco MP Transducer</tradeName>
    <deviceName>Avalon Toco MP Transducer</deviceName>
    <manufacturerName>Philips Medizin Systeme Böblingen GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1208010499</emdnCode>
    <emdnDescription>CARDIOTOCOGRAPHIC TELEMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>867248</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:08:52.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838093201</udiDi>
    <basicUdiDi>B-00884838093201</basicUdiDi>
    <tradeName>Avalon ECG/IUP Transducer</tradeName>
    <deviceName>Avalon ECG/IUP Transducer</deviceName>
    <manufacturerName>Philips Medizin Systeme Böblingen GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1208010499</emdnCode>
    <emdnDescription>CARDIOTOCOGRAPHIC TELEMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>867247</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:08:51.888Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838093195</udiDi>
    <basicUdiDi>B-00884838093195</basicUdiDi>
    <tradeName>Avalon Ultrasound Transducer</tradeName>
    <deviceName>Avalon Ultrasound Transducer</deviceName>
    <manufacturerName>Philips Medizin Systeme Böblingen GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1208010499</emdnCode>
    <emdnDescription>CARDIOTOCOGRAPHIC TELEMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>867246</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:08:47.888Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838093188</udiDi>
    <basicUdiDi>B-00884838093188</basicUdiDi>
    <tradeName>Avalon Toco+ MP Transducer</tradeName>
    <deviceName>Avalon Toco+ MP Transducer</deviceName>
    <manufacturerName>Philips Medizin Systeme Böblingen GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1208010499</emdnCode>
    <emdnDescription>CARDIOTOCOGRAPHIC TELEMETRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>867245</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:08:47.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278115171</udiDi>
    <basicUdiDi>8406821BUG00458HX</basicUdiDi>
    <tradeName>Novii+ Pod</tradeName>
    <deviceName>Novii+ Wireless Patch System</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>Z1208010403</emdnCode>
    <emdnDescription>TRANSMITTING UNITS FOR CARDIOTOCOGRAPHIC TELEMETRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5514130</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:50:45.417Z</lastUpdated>
  </row>
  <row>
    <udiDi>15060433670074</udiDi>
    <basicUdiDi>8406821BUG00146H9</basicUdiDi>
    <tradeName>Novii Patch</tradeName>
    <deviceName>Novii Patch</deviceName>
    <manufacturerName>Datex-Ohmeda Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002206</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1208010485</emdnCode>
    <emdnDescription>CARDIOTOCOGRAPHIC TELEMETRY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107-PT-004</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:48:58.766Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840682142724</udiDi>
    <basicUdiDi>8406821BUG00129H9</basicUdiDi>
    <tradeName>TRANSDUCER BELT – BUTTON - SINGLE PATIENT USE – 10/Box</tradeName>
    <deviceName>Transducer Belt</deviceName>
    <manufacturerName>Wipro GE Healthcare Private Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000016100</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1208010485</emdnCode>
    <emdnDescription>CARDIOTOCOGRAPHIC TELEMETRY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2015827-001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:46:54.554Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840682104111</udiDi>
    <basicUdiDi>8406821BUG00130GS</basicUdiDi>
    <tradeName>TOCO TRANSDUCER WATERTIGHT BUTTON</tradeName>
    <deviceName>TOCO Transducer</deviceName>
    <manufacturerName>Wipro GE Healthcare Private Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000016100</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1208010403</emdnCode>
    <emdnDescription>TRANSMITTING UNITS FOR CARDIOTOCOGRAPHIC TELEMETRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2264HAX</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:45:44.052Z</lastUpdated>
  </row>
  <row>
    <udiDi>07340194302447</udiDi>
    <basicUdiDi>7340194396A0DE</basicUdiDi>
    <tradeName>WEGAA® CTG 32mm</tradeName>
    <deviceName>CTG Transducer belt</deviceName>
    <manufacturerName>Cetro Medical AB</manufacturerName>
    <manufacturerSrn>SE-MF-000012172</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1208010485</emdnCode>
    <emdnDescription>CARDIOTOCOGRAPHIC TELEMETRY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WEGAA® CTG 32mm</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:40:30.093Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278212313</udiDi>
    <basicUdiDi>8406821BUG00458HX</basicUdiDi>
    <tradeName>Novii+ Interface</tradeName>
    <deviceName></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>Z1208010403</emdnCode>
    <emdnDescription>TRANSMITTING UNITS FOR CARDIOTOCOGRAPHIC TELEMETRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5514131</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T14:39:49.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060433670114</udiDi>
    <basicUdiDi>8406821BUG00136H6</basicUdiDi>
    <tradeName>NOVII INTERFACE CABLE - GE MECG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Datex-Ohmeda Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002206</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1208010480</emdnCode>
    <emdnDescription>CARDIOTOCOGRAPHIC TELEMETRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-PT-104</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-25T02:41:22.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060433670138</udiDi>
    <basicUdiDi>8406821BUG00136H6</basicUdiDi>
    <tradeName>NOVII INTERFACE CABLE - GE UA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Datex-Ohmeda Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002206</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1208010480</emdnCode>
    <emdnDescription>CARDIOTOCOGRAPHIC TELEMETRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-PT-106</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-25T02:41:22.304Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840682104227</udiDi>
    <basicUdiDi>8406821BUG00130GS</basicUdiDi>
    <tradeName>TOCO TRANSDUCER WATERTIGHT LOOP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wipro GE Healthcare Private Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000016100</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1208010403</emdnCode>
    <emdnDescription>TRANSMITTING UNITS FOR CARDIOTOCOGRAPHIC TELEMETRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2264LAX</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:04:39.733Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840682142571</udiDi>
    <basicUdiDi>8406821BUG00130GS</basicUdiDi>
    <tradeName>TOCO TRANSDUCER WATERTIGHT BUTTON AND LOOP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wipro GE Healthcare Private Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000016100</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1208010403</emdnCode>
    <emdnDescription>TRANSMITTING UNITS FOR CARDIOTOCOGRAPHIC TELEMETRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2108347-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:04:09.219Z</lastUpdated>
  </row>
</eudamedExport>