<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00749756142274</udiDi>
    <basicUdiDi>074975612510553</basicUdiDi>
    <tradeName>Ankle Contracture Boot</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PASSIVE ANKLE-FOOT ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4307D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:39:23.183Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756142311</udiDi>
    <basicUdiDi>074975612510553</basicUdiDi>
    <tradeName>Ankle Contracture Boot</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PASSIVE ANKLE-FOOT ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4300/05AB</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:39:23.162Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756143585</udiDi>
    <basicUdiDi>07497560861026R</basicUdiDi>
    <tradeName>Limb Holder, Wrist/Ankle</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M2011R-U</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:39:23.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756145534</udiDi>
    <basicUdiDi>0749756074T10B9</basicUdiDi>
    <tradeName>Bed Rail Pads</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M3000D08</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:39:23.113Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756146210</udiDi>
    <basicUdiDi>07497560746BPA6</basicUdiDi>
    <tradeName>Bed Pads</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PATIENT POSITIONING INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M10-321</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:39:23.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756146227</udiDi>
    <basicUdiDi>07497560746BPA6</basicUdiDi>
    <tradeName>Bed Pads</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PATIENT POSITIONING INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M10-323</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:39:23.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756158879</udiDi>
    <basicUdiDi>0749756N264B2JJ</basicUdiDi>
    <tradeName>Surgical Skin Markers</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SKIN MARKING DERMOGRAPHIC PENCILS AND PENS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26-003NS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:39:22.836Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756163279</udiDi>
    <basicUdiDi>07497560861036T</basicUdiDi>
    <tradeName>Hand Control Mitten</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M2039</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:39:22.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756163675</udiDi>
    <basicUdiDi>07497560861036T</basicUdiDi>
    <tradeName>Hand Control Mitten</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M2023S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:39:22.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756171823</udiDi>
    <basicUdiDi>0749756N064B9JA</basicUdiDi>
    <tradeName>Tube/Cord Holder</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17-9900</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:39:22.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756173636</udiDi>
    <basicUdiDi>0749756N194D3K4</basicUdiDi>
    <tradeName>Esmark Bandages</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BANDAGES - OTHER (see Y06 for collars, tutors, etc.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>35-412NS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:39:22.605Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756173889</udiDi>
    <basicUdiDi>07497560747N59T</basicUdiDi>
    <tradeName>IV ARMBOARD</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PATIENT POSITIONING INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>72-6100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:39:22.583Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756173896</udiDi>
    <basicUdiDi>07497560747N59T</basicUdiDi>
    <tradeName>IV ARMBOARD</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PATIENT POSITIONING INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>72-6101</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:39:22.563Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756173919</udiDi>
    <basicUdiDi>07497560747N59T</basicUdiDi>
    <tradeName>IV ARMBOARD</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PATIENT POSITIONING INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>72-6103</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:39:22.549Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756174084</udiDi>
    <basicUdiDi>0749756N274D2JX</basicUdiDi>
    <tradeName>Impervious Stockinette</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>COTTON WADDING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9818-54NS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:39:22.510Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756235952</udiDi>
    <basicUdiDi>0749756N154B1HW</basicUdiDi>
    <tradeName>Electrosurgical Tip Cleaner</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ELECTROSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32-200NS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:39:22.492Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756236751</udiDi>
    <basicUdiDi>0749756N194D3K4</basicUdiDi>
    <tradeName>Esmark Bandages</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BANDAGES - OTHER (see Y06 for collars, tutors, etc.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>35-309NS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:39:22.474Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756240482</udiDi>
    <basicUdiDi>0749756N064B3HW</basicUdiDi>
    <tradeName>Instrument Pad</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25-001NS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:39:22.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756240499</udiDi>
    <basicUdiDi>0749756N064B3HW</basicUdiDi>
    <tradeName>Instrument Pad</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25-002NS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:39:22.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>00749756240505</udiDi>
    <basicUdiDi>0749756N264B2JJ</basicUdiDi>
    <tradeName>Surgical Skin Markers</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SKIN MARKING DERMOGRAPHIC PENCILS AND PENS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26-005NS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:39:22.410Z</lastUpdated>
  </row>
</eudamedExport>