<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06944932785984</udiDi>
    <basicUdiDi>69449327FF01C02ED</basicUdiDi>
    <tradeName>All Silicone Foley Catheter with Temperature Sensor</tradeName>
    <deviceName>All Silicone Foley Catheter with Temperature Sensor</deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F01C021607</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:02:03.963Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944932785649</udiDi>
    <basicUdiDi>69449327FF01C00E9</basicUdiDi>
    <tradeName>All Silicone Foley Catheter with Temperature Sensor</tradeName>
    <deviceName>All Silicone Foley Catheter with Temperature Sensor</deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F01C010802</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:01:59.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936881164743</udiDi>
    <basicUdiDi>69449327FF01C01EB</basicUdiDi>
    <tradeName>All Silicone Foley Catheter with Temperature Sensor</tradeName>
    <deviceName>All Silicone Foley Catheter with Temperature Sensor</deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F01C011208</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:58:58.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250098849821</udiDi>
    <basicUdiDi>04250098810086F6</basicUdiDi>
    <tradeName>UROMED Temperature Measurement Catheter for Children</tradeName>
    <deviceName>TMC01</deviceName>
    <manufacturerName>UROMED Kurt Drews KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1610.10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:38:29.256Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250098849678</udiDi>
    <basicUdiDi>04250098810085F4</basicUdiDi>
    <tradeName>UROMED Temperature Measurement Catheter</tradeName>
    <deviceName>TMC01</deviceName>
    <manufacturerName>UROMED Kurt Drews KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1600.14</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:38:28.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250098849791</udiDi>
    <basicUdiDi>04250098810086F6</basicUdiDi>
    <tradeName>UROMED Temperature Measurement Catheter for Children</tradeName>
    <deviceName>TMC01</deviceName>
    <manufacturerName>UROMED Kurt Drews KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1610.08</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:34:30.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250098849647</udiDi>
    <basicUdiDi>04250098810085F4</basicUdiDi>
    <tradeName>UROMED Temperature Measurement Catheter</tradeName>
    <deviceName>TMC01</deviceName>
    <manufacturerName>UROMED Kurt Drews KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1600.12</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:34:26.506Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097052691</udiDi>
    <basicUdiDi>B-06948097052691</basicUdiDi>
    <tradeName>06948097052691</tradeName>
    <deviceName>Silicone Foley Catheters with Temperature probe for Single Use</deviceName>
    <manufacturerName>Haiyan Kangyuan Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001532</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:53:46.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097052684</udiDi>
    <basicUdiDi>B-06948097052684</basicUdiDi>
    <tradeName>06948097052684</tradeName>
    <deviceName>Silicone Foley Catheters with Temperature probe for Single Use</deviceName>
    <manufacturerName>Haiyan Kangyuan Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001532</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:53:42.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097052677</udiDi>
    <basicUdiDi>B-06948097052677</basicUdiDi>
    <tradeName>06948097052677</tradeName>
    <deviceName>Silicone Foley Catheters with Temperature probe for Single Use</deviceName>
    <manufacturerName>Haiyan Kangyuan Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001532</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:53:41.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097052660</udiDi>
    <basicUdiDi>B-06948097052660</basicUdiDi>
    <tradeName>06948097052660</tradeName>
    <deviceName>Silicone Foley Catheters with Temperature probe for Single Use</deviceName>
    <manufacturerName>Haiyan Kangyuan Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001532</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:53:40.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097052592</udiDi>
    <basicUdiDi>B-06948097052592</basicUdiDi>
    <tradeName>06948097052592</tradeName>
    <deviceName>Silicone Foley Catheters with Temperature probe for Single Use</deviceName>
    <manufacturerName>Haiyan Kangyuan Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001532</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:53:39.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097052585</udiDi>
    <basicUdiDi>B-06948097052585</basicUdiDi>
    <tradeName>06948097052585</tradeName>
    <deviceName>Silicone Foley Catheters with Temperature probe for Single Use</deviceName>
    <manufacturerName>Haiyan Kangyuan Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001532</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:53:35.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097052578</udiDi>
    <basicUdiDi>B-06948097052578</basicUdiDi>
    <tradeName>06948097052578</tradeName>
    <deviceName>Silicone Foley Catheters with Temperature probe for Single Use</deviceName>
    <manufacturerName>Haiyan Kangyuan Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001532</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:53:34.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097052561</udiDi>
    <basicUdiDi>B-06948097052561</basicUdiDi>
    <tradeName>06948097052561</tradeName>
    <deviceName>Silicone Foley Catheters with Temperature probe for Single Use</deviceName>
    <manufacturerName>Haiyan Kangyuan Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001532</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:53:34.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097052547</udiDi>
    <basicUdiDi>B-06948097052547</basicUdiDi>
    <tradeName>06948097052547</tradeName>
    <deviceName>Silicone Foley Catheters with Temperature probe for Single Use</deviceName>
    <manufacturerName>Haiyan Kangyuan Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001532</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:36:08.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097052523</udiDi>
    <basicUdiDi>B-06948097052523</basicUdiDi>
    <tradeName>06948097052523</tradeName>
    <deviceName>Silicone Foley Catheters with Temperature probe for Single Use</deviceName>
    <manufacturerName>Haiyan Kangyuan Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001532</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-24T21:48:14.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097052516</udiDi>
    <basicUdiDi>B-06948097052516</basicUdiDi>
    <tradeName>06948097052516</tradeName>
    <deviceName>Silicone Foley Catheters with Temperature probe for Single Use</deviceName>
    <manufacturerName>Haiyan Kangyuan Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001532</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-24T03:52:50.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704112122</udiDi>
    <basicUdiDi>B-24026704112122</basicUdiDi>
    <tradeName>RUSCH Sensor Tiemann (Series 400) Silicone Balloon Catheter for the Measuring of Temperature</tradeName>
    <deviceName>RUSCH SENSOR TIEMANN TEMP. MAN. CAT</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>178370-000180</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:33:52.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704112115</udiDi>
    <basicUdiDi>B-24026704112115</basicUdiDi>
    <tradeName>RUSCH Sensor Tiemann (Series 400) Silicone Balloon Catheter for the Measuring of Temperature</tradeName>
    <deviceName>RUSCH SENSOR TIEMANN TEMP. MAN. CAT</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>178370-000160</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:33:34.189Z</lastUpdated>
  </row>
</eudamedExport>