<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04897122903120</udiDi>
    <basicUdiDi>B-04897122903120</basicUdiDi>
    <tradeName>Medifoam</tradeName>
    <deviceName>Non-Adhesive Foam Dressing</deviceName>
    <manufacturerName>Fleming Medical Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014750</manufacturerSrn>
    <authorisedRepresentativeName>Fleming Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000012571</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04040601</emdnCode>
    <emdnDescription>POLYURETHANE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MD1386/1</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:17:55.438Z</lastUpdated>
  </row>
  <row>
    <udiDi>04897122903113</udiDi>
    <basicUdiDi>B-04897122903113</basicUdiDi>
    <tradeName>Medifoam</tradeName>
    <deviceName>Non-Adhesive Foam Heel Dressing</deviceName>
    <manufacturerName>Fleming Medical Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014750</manufacturerSrn>
    <authorisedRepresentativeName>Fleming Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000012571</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04040601</emdnCode>
    <emdnDescription>POLYURETHANE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MD1384/1</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:17:53.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>04718037842130</udiDi>
    <basicUdiDi>B-04718037842130</basicUdiDi>
    <tradeName>NanoSigma Oral Gel</tradeName>
    <deviceName>ORAL GEL</deviceName>
    <manufacturerName>NanoSigma Biotech. Co.,Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000023025</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M040499</emdnCode>
    <emdnDescription>DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPEC-OG-01</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:57:24.737Z</lastUpdated>
  </row>
  <row>
    <udiDi>04718037840075</udiDi>
    <basicUdiDi>B-04718037840075</basicUdiDi>
    <tradeName>NanoSigma Oral Gel</tradeName>
    <deviceName>ORAL GEL</deviceName>
    <manufacturerName>NanoSigma Biotech. Co.,Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000023025</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M040499</emdnCode>
    <emdnDescription>DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPEC-OG-01</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:57:09.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>04548762686415</udiDi>
    <basicUdiDi>B-04548762686415</basicUdiDi>
    <tradeName>PELNAC</tradeName>
    <deviceName>PELNAC</deviceName>
    <manufacturerName>GUNZE LIMITED</manufacturerName>
    <manufacturerSrn>JP-MF-000015551</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04041002</emdnCode>
    <emdnDescription>ANIMAL-DERIVED COLLAGEN DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PN-D82120</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:33:41.300Z</lastUpdated>
  </row>
  <row>
    <udiDi>04548762686408</udiDi>
    <basicUdiDi>B-04548762686408</basicUdiDi>
    <tradeName>PELNAC</tradeName>
    <deviceName>PELNAC</deviceName>
    <manufacturerName>GUNZE LIMITED</manufacturerName>
    <manufacturerSrn>JP-MF-000015551</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04041002</emdnCode>
    <emdnDescription>ANIMAL-DERIVED COLLAGEN DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PN-D82090</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:33:40.496Z</lastUpdated>
  </row>
  <row>
    <udiDi>04548762686392</udiDi>
    <basicUdiDi>B-04548762686392</basicUdiDi>
    <tradeName>PELNAC</tradeName>
    <deviceName>PELNAC</deviceName>
    <manufacturerName>GUNZE LIMITED</manufacturerName>
    <manufacturerSrn>JP-MF-000015551</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04041002</emdnCode>
    <emdnDescription>ANIMAL-DERIVED COLLAGEN DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PN-D82060</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:33:39.699Z</lastUpdated>
  </row>
  <row>
    <udiDi>04548762686385</udiDi>
    <basicUdiDi>B-04548762686385</basicUdiDi>
    <tradeName>PELNAC</tradeName>
    <deviceName>PELNAC</deviceName>
    <manufacturerName>GUNZE LIMITED</manufacturerName>
    <manufacturerSrn>JP-MF-000015551</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04041002</emdnCode>
    <emdnDescription>ANIMAL-DERIVED COLLAGEN DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PN-S82060</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:33:35.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>04548762686378</udiDi>
    <basicUdiDi>B-04548762686378</basicUdiDi>
    <tradeName>PELNAC</tradeName>
    <deviceName>PELNAC</deviceName>
    <manufacturerName>GUNZE LIMITED</manufacturerName>
    <manufacturerSrn>JP-MF-000015551</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04041002</emdnCode>
    <emdnDescription>ANIMAL-DERIVED COLLAGEN DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PN-S40030</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:33:34.904Z</lastUpdated>
  </row>
  <row>
    <udiDi>04548762583431</udiDi>
    <basicUdiDi>B-04548762583431</basicUdiDi>
    <tradeName>PELNAC</tradeName>
    <deviceName>PELNAC</deviceName>
    <manufacturerName>GUNZE LIMITED</manufacturerName>
    <manufacturerSrn>JP-MF-000015551</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04041002</emdnCode>
    <emdnDescription>ANIMAL-DERIVED COLLAGEN DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PN-F200240</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:33:34.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>04548762583424</udiDi>
    <basicUdiDi>B-04548762583424</basicUdiDi>
    <tradeName>PELNAC</tradeName>
    <deviceName>PELNAC</deviceName>
    <manufacturerName>GUNZE LIMITED</manufacturerName>
    <manufacturerSrn>JP-MF-000015551</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04041002</emdnCode>
    <emdnDescription>ANIMAL-DERIVED COLLAGEN DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PN-F120240</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:33:33.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>04548366608578</udiDi>
    <basicUdiDi>B-04548366608578</basicUdiDi>
    <tradeName>PELNAC</tradeName>
    <deviceName>PELNAC</deviceName>
    <manufacturerName>GUNZE LIMITED</manufacturerName>
    <manufacturerSrn>JP-MF-000015551</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04041002</emdnCode>
    <emdnDescription>ANIMAL-DERIVED COLLAGEN DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PN-S82120T</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:33:13.228Z</lastUpdated>
  </row>
  <row>
    <udiDi>04548366608561</udiDi>
    <basicUdiDi>B-04548366608561</basicUdiDi>
    <tradeName>PELNAC</tradeName>
    <deviceName>PELNAC</deviceName>
    <manufacturerName>GUNZE LIMITED</manufacturerName>
    <manufacturerSrn>JP-MF-000015551</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04041002</emdnCode>
    <emdnDescription>ANIMAL-DERIVED COLLAGEN DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PN-S82090T</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:33:12.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>04548366608554</udiDi>
    <basicUdiDi>B-04548366608554</basicUdiDi>
    <tradeName>PELNAC</tradeName>
    <deviceName>PELNAC</deviceName>
    <manufacturerName>GUNZE LIMITED</manufacturerName>
    <manufacturerSrn>JP-MF-000015551</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04041002</emdnCode>
    <emdnDescription>ANIMAL-DERIVED COLLAGEN DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PN-S82060T</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:33:12.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>04548366608530</udiDi>
    <basicUdiDi>B-04548366608530</basicUdiDi>
    <tradeName>PELNAC</tradeName>
    <deviceName>PELNAC</deviceName>
    <manufacturerName>GUNZE LIMITED</manufacturerName>
    <manufacturerSrn>JP-MF-000015551</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04041002</emdnCode>
    <emdnDescription>ANIMAL-DERIVED COLLAGEN DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PN-S40030T</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:33:07.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>04548366608523</udiDi>
    <basicUdiDi>B-04548366608523</basicUdiDi>
    <tradeName>PELNAC</tradeName>
    <deviceName>PELNAC</deviceName>
    <manufacturerName>GUNZE LIMITED</manufacturerName>
    <manufacturerSrn>JP-MF-000015551</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04041002</emdnCode>
    <emdnDescription>ANIMAL-DERIVED COLLAGEN DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PN-S20030T</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:33:05.854Z</lastUpdated>
  </row>
  <row>
    <udiDi>04548366608516</udiDi>
    <basicUdiDi>B-04548366608516</basicUdiDi>
    <tradeName>PELNAC</tradeName>
    <deviceName>PELNAC</deviceName>
    <manufacturerName>GUNZE LIMITED</manufacturerName>
    <manufacturerSrn>JP-MF-000015551</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04041002</emdnCode>
    <emdnDescription>ANIMAL-DERIVED COLLAGEN DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PN-S200240T</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:33:05.055Z</lastUpdated>
  </row>
  <row>
    <udiDi>04548366608509</udiDi>
    <basicUdiDi>B-04548366608509</basicUdiDi>
    <tradeName>PELNAC</tradeName>
    <deviceName>PELNAC</deviceName>
    <manufacturerName>GUNZE LIMITED</manufacturerName>
    <manufacturerSrn>JP-MF-000015551</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04041002</emdnCode>
    <emdnDescription>ANIMAL-DERIVED COLLAGEN DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PN-S120240T</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:33:04.287Z</lastUpdated>
  </row>
  <row>
    <udiDi>04548366293132</udiDi>
    <basicUdiDi>B-04548366293132</basicUdiDi>
    <tradeName>PELNAC</tradeName>
    <deviceName>PELNAC</deviceName>
    <manufacturerName>GUNZE LIMITED</manufacturerName>
    <manufacturerSrn>JP-MF-000015551</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04041002</emdnCode>
    <emdnDescription>ANIMAL-DERIVED COLLAGEN DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PN-R40030</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:32:28.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>04548366293125</udiDi>
    <basicUdiDi>B-04548366293125</basicUdiDi>
    <tradeName>PELNAC</tradeName>
    <deviceName>PELNAC</deviceName>
    <manufacturerName>GUNZE LIMITED</manufacturerName>
    <manufacturerSrn>JP-MF-000015551</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04041002</emdnCode>
    <emdnDescription>ANIMAL-DERIVED COLLAGEN DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PN-F40060</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:32:27.545Z</lastUpdated>
  </row>
</eudamedExport>