<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04719873370153</udiDi>
    <basicUdiDi>471987337RootiCare8E</basicUdiDi>
    <tradeName>Rooti</tradeName>
    <deviceName>RootiCare System</deviceName>
    <manufacturerName>Rooti Labs Limited.</manufacturerName>
    <manufacturerSrn>TW-MF-000004839</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050892</emdnCode>
    <emdnDescription>CARDIAC TELEMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RootiCare</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:17:33.255Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719873370139</udiDi>
    <basicUdiDi>471987337RootiRxPatchTH8</basicUdiDi>
    <tradeName>Rooti Rx</tradeName>
    <deviceName>Rooti Rx Patch T</deviceName>
    <manufacturerName>Rooti Labs Limited.</manufacturerName>
    <manufacturerSrn>TW-MF-000004839</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050880</emdnCode>
    <emdnDescription>CARDIAC TELEMETRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RXAP02</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:17:32.457Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719873370092</udiDi>
    <basicUdiDi>471987337RootiRxDJ</basicUdiDi>
    <tradeName>Rooti Rx</tradeName>
    <deviceName>Rooti Rx System</deviceName>
    <manufacturerName>Rooti Labs Limited.</manufacturerName>
    <manufacturerSrn>TW-MF-000004839</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RXAP02, RXAP03, RXMD01, RXMD02, ASCD01</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:17:31.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719873370146</udiDi>
    <basicUdiDi>471987337RootiRxPatchTH8</basicUdiDi>
    <tradeName>Rooti Rx</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rooti Labs Limited.</manufacturerName>
    <manufacturerSrn>TW-MF-000004839</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050880</emdnCode>
    <emdnDescription>CARDIAC TELEMETRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RXAP02-50</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:15:59.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719873370122</udiDi>
    <basicUdiDi>471987337RootiRxDJ</basicUdiDi>
    <tradeName>Rooti Rx</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rooti Labs Limited.</manufacturerName>
    <manufacturerSrn>TW-MF-000004839</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050880</emdnCode>
    <emdnDescription>CARDIAC TELEMETRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RXAP01-50</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:15:57.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719873370115</udiDi>
    <basicUdiDi>471987337RootiRxDJ</basicUdiDi>
    <tradeName>Rooti Rx</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rooti Labs Limited.</manufacturerName>
    <manufacturerSrn>TW-MF-000004839</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12050880</emdnCode>
    <emdnDescription>CARDIAC TELEMETRY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RXAP01</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:15:56.566Z</lastUpdated>
  </row>
</eudamedExport>