<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04251978600242</udiDi>
    <basicUdiDi>42519786030082R</basicUdiDi>
    <tradeName>Sensor SpO2 Kinder, 4-40 kg, DSUB</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dr. Fenyves und Gut Deutschland GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005715</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>920127</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T11:20:09.834Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251978600365</udiDi>
    <basicUdiDi>42519786030082R</basicUdiDi>
    <tradeName>Fingersensor SpO2 Erwachsene, mit Lemostecker</tradeName>
    <deviceName>Fingersensoren SpO2</deviceName>
    <manufacturerName>Dr. Fenyves und Gut Deutschland GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005715</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>920100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T11:20:09.748Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251978600372</udiDi>
    <basicUdiDi>42519786030082R</basicUdiDi>
    <tradeName>Fingersensor SpO2 Erwachsene, mit Hirosestecker</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dr. Fenyves und Gut Deutschland GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005715</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>929100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T11:19:50.876Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251978600501</udiDi>
    <basicUdiDi>42519786030082R</basicUdiDi>
    <tradeName>Fingersensor SpO2 Erwachsene mit Lemostecker</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dr. Fenyves und Gut Deutschland GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005715</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C900301</emdnCode>
    <emdnDescription>PULSE OXIMETER SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>920102</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T11:19:50.836Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987350748188</udiDi>
    <basicUdiDi>498735026TRBDQB</basicUdiDi>
    <tradeName>TR Band Distal</tradeName>
    <deviceName>TR Band Distal</deviceName>
    <manufacturerName>Terumo Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000017478</manufacturerSrn>
    <authorisedRepresentativeName>TERUMO EUROPE N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000001433</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C90010301</emdnCode>
    <emdnDescription>HAEMOSTASIS MECHANICAL SYSTEMS (INCLUDING SINGLE-USE TOURNIQUETS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XX*RF06D</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-29T20:05:25.708Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268108455</udiDi>
    <basicUdiDi>08412681HydroRadial-CLIPJ</basicUdiDi>
    <tradeName>Elite HV® R Introducer Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C900101</emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLI-132-07</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:48:27.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268108462</udiDi>
    <basicUdiDi>08412681HydroRadial-CLIPJ</basicUdiDi>
    <tradeName>Elite HV® R Introducer Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C900101</emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLI-132-45</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:48:27.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268108479</udiDi>
    <basicUdiDi>08412681HydroRadial-CLIPJ</basicUdiDi>
    <tradeName>Elite HV® R Introducer Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C900101</emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLI-132-55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:48:27.373Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268108486</udiDi>
    <basicUdiDi>08412681HydroRadial-CLIPJ</basicUdiDi>
    <tradeName>Elite HV® R Introducer Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C900101</emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLI-133-06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:48:27.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268108493</udiDi>
    <basicUdiDi>08412681HydroRadial-CLIPJ</basicUdiDi>
    <tradeName>Elite HV® R Introducer Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C900101</emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLI-133-07</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:48:27.326Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268108509</udiDi>
    <basicUdiDi>08412681HydroRadial-CLIPJ</basicUdiDi>
    <tradeName>Elite HV® R Introducer Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C900101</emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLI-133-45</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:48:27.306Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268108516</udiDi>
    <basicUdiDi>08412681HydroRadial-CLIPJ</basicUdiDi>
    <tradeName>Elite HV® R Introducer Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C900101</emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLI-133-55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:48:27.290Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268108523</udiDi>
    <basicUdiDi>08412681HydroRadial-CLIPJ</basicUdiDi>
    <tradeName>Elite HV® R Introducer Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C900101</emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLI-134-06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:48:27.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268108530</udiDi>
    <basicUdiDi>08412681HydroRadial-CLIPJ</basicUdiDi>
    <tradeName>Elite HV® R Introducer Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C900101</emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLI-134-07</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:48:27.256Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268108547</udiDi>
    <basicUdiDi>08412681HydroRadial-CLIPJ</basicUdiDi>
    <tradeName>Elite HV® R Introducer Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C900101</emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLI-134-45</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:48:27.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268108554</udiDi>
    <basicUdiDi>08412681HydroRadial-CLIPJ</basicUdiDi>
    <tradeName>Elite HV® R Introducer Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C900101</emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLI-134-55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:48:27.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268108561</udiDi>
    <basicUdiDi>08412681HydroRadial-CLIPJ</basicUdiDi>
    <tradeName>Elite HV® R Introducer Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C900101</emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLI-225-06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:48:27.192Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268108578</udiDi>
    <basicUdiDi>08412681HydroRadial-CLIPJ</basicUdiDi>
    <tradeName>Elite HV® R Introducer Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C900101</emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLI-225-07</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:48:27.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268108585</udiDi>
    <basicUdiDi>08412681HydroRadial-CLIPJ</basicUdiDi>
    <tradeName>Elite HV® R Introducer Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C900101</emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLI-225-45</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:48:27.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841268108592</udiDi>
    <basicUdiDi>08412681HydroRadial-CLIPJ</basicUdiDi>
    <tradeName>Elite HV® R Introducer Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Galt Medical Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000001777</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C900101</emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLI-225-55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T17:48:27.137Z</lastUpdated>
  </row>
</eudamedExport>