<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00749756596572</udiDi>
    <basicUdiDi>B-00749756596572</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>81-040409EU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:29:37.145Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756596565</udiDi>
    <basicUdiDi>B-00749756596565</basicUdiDi>
    <tradeName>General Purpose Temperature Probe</tradeName>
    <deviceName>General Purpose 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>81-020412EU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:29:36.448Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756596541</udiDi>
    <basicUdiDi>B-00749756596541</basicUdiDi>
    <tradeName>Skin Temperature Sensor</tradeName>
    <deviceName>Skin 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>V03010299</emdnCode>
    <emdnDescription>BODY TEMPERATURE MONITORING PROBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81-010400EU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:29:20.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756566995</udiDi>
    <basicUdiDi>B-00749756566995</basicUdiDi>
    <tradeName>Electrosurgical Pencil, Button Switch</tradeName>
    <deviceName>Electrosurgical Pencil, Button Switch</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>K0299</emdnCode>
    <emdnDescription>ELECTROSURGERY DEVICES, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88-000223</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:29:19.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756566964</udiDi>
    <basicUdiDi>B-00749756566964</basicUdiDi>
    <tradeName>Breazeale Fine Touch Rocker Pencil</tradeName>
    <deviceName>Breazeale Fine Touch Rocker Pencil</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>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88-FT01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:29:15.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756557450</udiDi>
    <basicUdiDi>B-00749756557450</basicUdiDi>
    <tradeName>Insufflation Tubing,Laparoscopic</tradeName>
    <deviceName>Insufflation Tubing,Laparoscopic</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>A060102</emdnCode>
    <emdnDescription>SURGICAL DRAINAGE CONNECTION MEDICAL TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>28-0217</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:29:14.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756557443</udiDi>
    <basicUdiDi>B-00749756557443</basicUdiDi>
    <tradeName>Tubing, Insuf w/.3 Micr Filter</tradeName>
    <deviceName>Tubing, Insuf w/.3 Micr Filter</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>A060102</emdnCode>
    <emdnDescription>SURGICAL DRAINAGE CONNECTION MEDICAL TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>28-0216</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:29:13.882Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756557436</udiDi>
    <basicUdiDi>B-00749756557436</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>28-0804</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:29:13.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756557429</udiDi>
    <basicUdiDi>B-00749756557429</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>28-0802</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:29:08.290Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756379816</udiDi>
    <basicUdiDi>B-00749756379816</basicUdiDi>
    <tradeName>Transeal Maxx</tradeName>
    <deviceName>Transeal Maxx</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>M0499</emdnCode>
    <emdnDescription>SPECIAL DRESSINGS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>46-326X-EU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:29:07.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756379809</udiDi>
    <basicUdiDi>B-00749756379809</basicUdiDi>
    <tradeName>Transeal TR Dressing Patch2 1/2 X 2 3/4 Transeal Maxx Patch2 1/2 X 2 3/4 (6.4 cm x 7 cm)</tradeName>
    <deviceName>Transeal Maxx Patch2 1/2 X 2 3/4 (6.4 cm x 7 cm)</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>M0499</emdnCode>
    <emdnDescription>SPECIAL DRESSINGS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>46-302X-EU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:29:06.682Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756379793</udiDi>
    <basicUdiDi>B-00749756379793</basicUdiDi>
    <tradeName>Transeal TR Dressing Patch2 1/2 X 2 3/4</tradeName>
    <deviceName>Transeal TR Dressing Patch2 1/2 X 2 3/4</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>M0499</emdnCode>
    <emdnDescription>SPECIAL DRESSINGS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>46-302TR-EU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:29:05.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756379267</udiDi>
    <basicUdiDi>B-00749756379267</basicUdiDi>
    <tradeName>Transeal Triple Release</tradeName>
    <deviceName>Transeal Triple Release</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>M0499</emdnCode>
    <emdnDescription>SPECIAL DRESSINGS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>46-326B-EU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:29:01.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756356688</udiDi>
    <basicUdiDi>B-00749756356688</basicUdiDi>
    <tradeName>Black Foam, Thin, NPWT</tradeName>
    <deviceName>Black Foam, Thin, NPWT</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>M040499</emdnCode>
    <emdnDescription>DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NP-206-EU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:29:01.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756356671</udiDi>
    <basicUdiDi>B-00749756356671</basicUdiDi>
    <tradeName>Black Foam, Thin, NPWT</tradeName>
    <deviceName>Black Foam, Thin, NPWT</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>M040499</emdnCode>
    <emdnDescription>DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NP-205-EU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:29:00.282Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756356664</udiDi>
    <basicUdiDi>B-00749756356664</basicUdiDi>
    <tradeName>Black Foam, Thin, NPWT</tradeName>
    <deviceName>Black Foam, Thin, NPWT</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>M040499</emdnCode>
    <emdnDescription>DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NP-204-EU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:28:59.582Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756356657</udiDi>
    <basicUdiDi>B-00749756356657</basicUdiDi>
    <tradeName>Black Foam, NPWT</tradeName>
    <deviceName>Black Foam, NPWT</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>M040499</emdnCode>
    <emdnDescription>DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NP-203-EU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:28:54.675Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756356640</udiDi>
    <basicUdiDi>B-00749756356640</basicUdiDi>
    <tradeName>Black Foam, NPWT</tradeName>
    <deviceName>Black Foam, NPWT</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>M040499</emdnCode>
    <emdnDescription>DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NP-202-EU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:28:53.868Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756356633</udiDi>
    <basicUdiDi>B-00749756356633</basicUdiDi>
    <tradeName>Black Foam, NPWT</tradeName>
    <deviceName>Black Foam, NPWT</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>M040499</emdnCode>
    <emdnDescription>DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NP-201-EU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:28:53.065Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756356626</udiDi>
    <basicUdiDi>B-00749756356626</basicUdiDi>
    <tradeName>Black Foam, NPWT</tradeName>
    <deviceName>Black Foam, NPWT</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>M040499</emdnCode>
    <emdnDescription>DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NP-200-EU</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:28:52.268Z</lastUpdated>
  </row>
</eudamedExport>