<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00846159002362</udiDi>
    <basicUdiDi>B-00846159002362</basicUdiDi>
    <tradeName>00846159002362</tradeName>
    <deviceName>Scanlan SUTURE-STATT® suture tags</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030101</emdnCode>
    <emdnDescription>COVER CAPS, INSTRUMENTS AND EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-520</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:43:19.987Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159002355</udiDi>
    <basicUdiDi>B-00846159002355</basicUdiDi>
    <tradeName>00846159002355</tradeName>
    <deviceName>Scanlan PINCAP® orthopedic pin protectors</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030101</emdnCode>
    <emdnDescription>COVER CAPS, INSTRUMENTS AND EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301-0130</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:43:19.194Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159002348</udiDi>
    <basicUdiDi>B-00846159002348</basicUdiDi>
    <tradeName>00846159002348</tradeName>
    <deviceName>Scanlan PINCAP® orthopedic pin protectors</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030101</emdnCode>
    <emdnDescription>COVER CAPS, INSTRUMENTS AND EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301-0120</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:43:18.386Z</lastUpdated>
  </row>
  <row>
    <udiDi>00846159002331</udiDi>
    <basicUdiDi>B-00846159002331</basicUdiDi>
    <tradeName>00846159002331</tradeName>
    <deviceName>Scanlan PINCAP® orthopedic pin protectors</deviceName>
    <manufacturerName>Scanlan International Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010251</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030101</emdnCode>
    <emdnDescription>COVER CAPS, INSTRUMENTS AND EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301-0110</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:43:14.396Z</lastUpdated>
  </row>
  <row>
    <udiDi>00845225012700</udiDi>
    <basicUdiDi>B-00845225012700</basicUdiDi>
    <tradeName>R-100 Sterile Equipment Cover</tradeName>
    <deviceName>Sterile Drapes</deviceName>
    <manufacturerName>Volcano Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020094</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PBKBG</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:43:12.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>00845225012694</udiDi>
    <basicUdiDi>B-00845225012694</basicUdiDi>
    <tradeName>Digital IVUS Sterile Equipment Cover</tradeName>
    <deviceName>Sterile Drapes</deviceName>
    <manufacturerName>Volcano Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020094</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5902VC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:43:11.985Z</lastUpdated>
  </row>
  <row>
    <udiDi>00845225012687</udiDi>
    <basicUdiDi>B-00845225012687</basicUdiDi>
    <tradeName>SpinVision Sterile Equipment Cover</tradeName>
    <deviceName>Sterile Drapes</deviceName>
    <manufacturerName>Volcano Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020094</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>891BG</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T15:43:07.178Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920130531912</udiDi>
    <basicUdiDi>69201305AD01E9</basicUdiDi>
    <tradeName>06920130531912</tradeName>
    <deviceName>Adult Diaper</deviceName>
    <manufacturerName>G. T. PAPER CO., LTD. PUTIAN FUJIAN</manufacturerName>
    <manufacturerSrn>CN-MF-000043034</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T04010103</emdnCode>
    <emdnDescription>INCONTINENCE NAPPIES WITH INTEGRATED FIXING SYSTEM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M#</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-01T14:12:14.888Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920130531929</udiDi>
    <basicUdiDi>69201305AD01E9</basicUdiDi>
    <tradeName>06920130531929</tradeName>
    <deviceName></deviceName>
    <manufacturerName>G. T. PAPER CO., LTD. PUTIAN FUJIAN</manufacturerName>
    <manufacturerSrn>CN-MF-000043034</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T04010103</emdnCode>
    <emdnDescription>INCONTINENCE NAPPIES WITH INTEGRATED FIXING SYSTEM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L#</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-01T14:12:14.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920130531936</udiDi>
    <basicUdiDi>69201305AD01E9</basicUdiDi>
    <tradeName>06920130531936</tradeName>
    <deviceName></deviceName>
    <manufacturerName>G. T. PAPER CO., LTD. PUTIAN FUJIAN</manufacturerName>
    <manufacturerSrn>CN-MF-000043034</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T04010103</emdnCode>
    <emdnDescription>INCONTINENCE NAPPIES WITH INTEGRATED FIXING SYSTEM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XL#</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-01T14:12:14.842Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920130531943</udiDi>
    <basicUdiDi>69201305AD01E9</basicUdiDi>
    <tradeName>06920130531943</tradeName>
    <deviceName></deviceName>
    <manufacturerName>G. T. PAPER CO., LTD. PUTIAN FUJIAN</manufacturerName>
    <manufacturerSrn>CN-MF-000043034</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T04010103</emdnCode>
    <emdnDescription>INCONTINENCE NAPPIES WITH INTEGRATED FIXING SYSTEM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XXL#</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-01T14:12:14.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920130531950</udiDi>
    <basicUdiDi>69201305APD01AY</basicUdiDi>
    <tradeName>06920130531950</tradeName>
    <deviceName>Adult Pants Diaper</deviceName>
    <manufacturerName>G. T. PAPER CO., LTD. PUTIAN FUJIAN</manufacturerName>
    <manufacturerSrn>CN-MF-000043034</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T04010103</emdnCode>
    <emdnDescription>INCONTINENCE NAPPIES WITH INTEGRATED FIXING SYSTEM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M#</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-01T14:12:14.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920130531967</udiDi>
    <basicUdiDi>69201305APD01AY</basicUdiDi>
    <tradeName>06920130531967</tradeName>
    <deviceName></deviceName>
    <manufacturerName>G. T. PAPER CO., LTD. PUTIAN FUJIAN</manufacturerName>
    <manufacturerSrn>CN-MF-000043034</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T04010103</emdnCode>
    <emdnDescription>INCONTINENCE NAPPIES WITH INTEGRATED FIXING SYSTEM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L#</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-01T14:12:14.784Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920130531974</udiDi>
    <basicUdiDi>69201305APD01AY</basicUdiDi>
    <tradeName>06920130531974</tradeName>
    <deviceName></deviceName>
    <manufacturerName>G. T. PAPER CO., LTD. PUTIAN FUJIAN</manufacturerName>
    <manufacturerSrn>CN-MF-000043034</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T04010103</emdnCode>
    <emdnDescription>INCONTINENCE NAPPIES WITH INTEGRATED FIXING SYSTEM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XL#</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-01T14:12:14.758Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920130531981</udiDi>
    <basicUdiDi>69201305APD01AY</basicUdiDi>
    <tradeName>06920130531981</tradeName>
    <deviceName></deviceName>
    <manufacturerName>G. T. PAPER CO., LTD. PUTIAN FUJIAN</manufacturerName>
    <manufacturerSrn>CN-MF-000043034</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T04010103</emdnCode>
    <emdnDescription>INCONTINENCE NAPPIES WITH INTEGRATED FIXING SYSTEM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XXL#</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-01T14:12:14.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920130531998</udiDi>
    <basicUdiDi>69201305U01T6</basicUdiDi>
    <tradeName>06920130531998</tradeName>
    <deviceName>Underpad</deviceName>
    <manufacturerName>G. T. PAPER CO., LTD. PUTIAN FUJIAN</manufacturerName>
    <manufacturerSrn>CN-MF-000043034</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T04010101</emdnCode>
    <emdnDescription>RECTANGULAR INCONTINENCE NAPPIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60cm*90cm</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-01T14:12:14.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920130532001</udiDi>
    <basicUdiDi>69201305IPLady01C5</basicUdiDi>
    <tradeName>06920130532001</tradeName>
    <deviceName>Incontinence Pads</deviceName>
    <manufacturerName>G. T. PAPER CO., LTD. PUTIAN FUJIAN</manufacturerName>
    <manufacturerSrn>CN-MF-000043034</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T04010199</emdnCode>
    <emdnDescription>INCONTINENCE NAPPIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lady Pads（240mm）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-01T14:12:14.700Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920130532018</udiDi>
    <basicUdiDi>69201305IPLady01C5</basicUdiDi>
    <tradeName>06920130532018</tradeName>
    <deviceName></deviceName>
    <manufacturerName>G. T. PAPER CO., LTD. PUTIAN FUJIAN</manufacturerName>
    <manufacturerSrn>CN-MF-000043034</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T04010199</emdnCode>
    <emdnDescription>INCONTINENCE NAPPIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>310MM</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-01T14:12:14.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920130532025</udiDi>
    <basicUdiDi>69201305IPLady01C5</basicUdiDi>
    <tradeName>06920130532025</tradeName>
    <deviceName></deviceName>
    <manufacturerName>G. T. PAPER CO., LTD. PUTIAN FUJIAN</manufacturerName>
    <manufacturerSrn>CN-MF-000043034</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T04010199</emdnCode>
    <emdnDescription>INCONTINENCE NAPPIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>420MM</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-01T14:12:14.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920130532032</udiDi>
    <basicUdiDi>69201305IPMen01U2</basicUdiDi>
    <tradeName>06920130532032</tradeName>
    <deviceName>Men Protector Pads</deviceName>
    <manufacturerName>G. T. PAPER CO., LTD. PUTIAN FUJIAN</manufacturerName>
    <manufacturerSrn>CN-MF-000043034</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T04010199</emdnCode>
    <emdnDescription>INCONTINENCE NAPPIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>255MM</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-01T14:12:14.631Z</lastUpdated>
  </row>
</eudamedExport>