<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00749756820912</udiDi>
    <basicUdiDi>B-00749756820912</basicUdiDi>
    <tradeName>General Purpose Temperature Probe, Soft</tradeName>
    <deviceName>General Purpose Temperature Probe, Soft</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V03010299</emdnCode>
    <emdnDescription>BODY TEMPERATURE MONITORING PROBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81-02S409EU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:30:09.180Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756805469</udiDi>
    <basicUdiDi>B-00749756805469</basicUdiDi>
    <tradeName>Instrument Pad</tradeName>
    <deviceName>Instrument Pad</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25-012</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:30:08.376Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756791045</udiDi>
    <basicUdiDi>B-00749756791045</basicUdiDi>
    <tradeName>Nasopharyngeal Temperature Probe</tradeName>
    <deviceName>00749756791045</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V03010299</emdnCode>
    <emdnDescription>BODY TEMPERATURE MONITORING PROBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81-025400EU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:30:04.364Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756790932</udiDi>
    <basicUdiDi>B-00749756790932</basicUdiDi>
    <tradeName>Nasopharyngeal Temperature Probe</tradeName>
    <deviceName>Nasopharyngeal Temperature Probe</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V03010299</emdnCode>
    <emdnDescription>BODY TEMPERATURE MONITORING PROBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81-025409EU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:30:03.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756671361</udiDi>
    <basicUdiDi>B-00749756671361</basicUdiDi>
    <tradeName>HYDRO-TEMP Neonatal Temperature Skin Sensor</tradeName>
    <deviceName>HYDRO-TEMP Neonatal Temperature Skin Sensor</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V03010299</emdnCode>
    <emdnDescription>BODY TEMPERATURE MONITORING PROBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HNICU-37</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:30:02.763Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756670203</udiDi>
    <basicUdiDi>B-00749756670203</basicUdiDi>
    <tradeName>HYDRO-TEMP Neonatal Temperature Skin Sensor</tradeName>
    <deviceName>HYDRO-TEMP Neonatal Temperature Skin Sensor</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V03010299</emdnCode>
    <emdnDescription>BODY TEMPERATURE MONITORING PROBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HNICU-36</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:30:01.978Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756666688</udiDi>
    <basicUdiDi>B-00749756666688</basicUdiDi>
    <tradeName>HYDRO-TEMP Neonatal Temperature Skin Sensor</tradeName>
    <deviceName>HYDRO-TEMP Neonatal Temperature Skin Sensor</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V03010299</emdnCode>
    <emdnDescription>BODY TEMPERATURE MONITORING PROBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HNICU-38</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:29:57.979Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756650809</udiDi>
    <basicUdiDi>B-00749756650809</basicUdiDi>
    <tradeName>Light Handles, Rigid</tradeName>
    <deviceName>Light Handles, Rigid</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26-022B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:29:57.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756647687</udiDi>
    <basicUdiDi>B-00749756647687</basicUdiDi>
    <tradeName>Impervious Stockinette</tradeName>
    <deviceName>Impervious Stockinette</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M010199</emdnCode>
    <emdnDescription>COTTON WADDING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9416-54</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:29:56.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756645768</udiDi>
    <basicUdiDi>B-00749756645768</basicUdiDi>
    <tradeName>Impervious Stockinette</tradeName>
    <deviceName>Impervious Stockinette</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M010199</emdnCode>
    <emdnDescription>COTTON WADDING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9412-54</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:29:55.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756645737</udiDi>
    <basicUdiDi>B-00749756645737</basicUdiDi>
    <tradeName>Impervious Stockinette</tradeName>
    <deviceName>Impervious Stockinette</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M010199</emdnCode>
    <emdnDescription>COTTON WADDING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9409-54</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:29:51.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756645720</udiDi>
    <basicUdiDi>B-00749756645720</basicUdiDi>
    <tradeName>Impervious Stockinette</tradeName>
    <deviceName>Impervious Stockinette</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M010199</emdnCode>
    <emdnDescription>COTTON WADDING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9408-38</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:29:50.771Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756617482</udiDi>
    <basicUdiDi>B-00749756617482</basicUdiDi>
    <tradeName>Laparoscopic Dissector</tradeName>
    <deviceName>Laparoscopic Dissector</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M040799</emdnCode>
    <emdnDescription>SPECIAL PADS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>28-BTD05</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:29:49.964Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756596688</udiDi>
    <basicUdiDi>B-00749756596688</basicUdiDi>
    <tradeName>Tympanic Probe</tradeName>
    <deviceName>Tympanic Probe</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V03010299</emdnCode>
    <emdnDescription>BODY TEMPERATURE MONITORING PROBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81-090400EU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:29:49.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756596671</udiDi>
    <basicUdiDi>B-00749756596671</basicUdiDi>
    <tradeName>Foley Catheter with Temperature Sensor</tradeName>
    <deviceName>Foley Catheter with Temperature Sensor</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</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>81-080418EU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:29:45.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756596664</udiDi>
    <basicUdiDi>B-00749756596664</basicUdiDi>
    <tradeName>Foley Catheter with Temperature Sensor</tradeName>
    <deviceName>Foley Catheter with Temperature Sensor</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</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>81-080416EU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:29:44.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756596657</udiDi>
    <basicUdiDi>B-00749756596657</basicUdiDi>
    <tradeName>Foley Catheter with Temperature Sensor</tradeName>
    <deviceName>Foley Catheter with Temperature Sensor</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</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>81-080414EU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:29:43.566Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756596602</udiDi>
    <basicUdiDi>B-00749756596602</basicUdiDi>
    <tradeName>Esophageal Stethoscope w/Temperature Sensor</tradeName>
    <deviceName>Esophageal Stethoscope w/Temperature Sensor</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C9005</emdnCode>
    <emdnDescription>PHONENDOSCOPES AND STETHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81-040424EU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:29:42.752Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756596596</udiDi>
    <basicUdiDi>B-00749756596596</basicUdiDi>
    <tradeName>Esophageal Stethoscope w/Temperature Sensor</tradeName>
    <deviceName>Esophageal Stethoscope w/Temperature Sensor</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C9005</emdnCode>
    <emdnDescription>PHONENDOSCOPES AND STETHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81-040418EU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:29:38.749Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756596589</udiDi>
    <basicUdiDi>B-00749756596589</basicUdiDi>
    <tradeName>Esophageal Stethoscope w/Temperature Sensor</tradeName>
    <deviceName>Esophageal Stethoscope w/Temperature Sensor</deviceName>
    <manufacturerName>DeRoyal Industries, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002102</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C9005</emdnCode>
    <emdnDescription>PHONENDOSCOPES AND STETHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81-040412EU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:29:37.946Z</lastUpdated>
  </row>
</eudamedExport>