<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04710961936893</udiDi>
    <basicUdiDi>B-04710961936893</basicUdiDi>
    <tradeName>Silicone Nephrostomy Catheter</tradeName>
    <deviceName>Silicone Nephrostomy Catheter</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U040203</emdnCode>
    <emdnDescription>NEPHROSTOMY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4853-0216</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:09:11.374Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961936886</udiDi>
    <basicUdiDi>B-04710961936886</basicUdiDi>
    <tradeName>Silicone Nephrostomy Catheter</tradeName>
    <deviceName>Silicone Nephrostomy Catheter</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U040203</emdnCode>
    <emdnDescription>NEPHROSTOMY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4853-0214</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:09:09.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961936879</udiDi>
    <basicUdiDi>B-04710961936879</basicUdiDi>
    <tradeName>Silicone Nephrostomy Catheter</tradeName>
    <deviceName>Silicone Nephrostomy Catheter</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U040203</emdnCode>
    <emdnDescription>NEPHROSTOMY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4853-0212</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:09:07.374Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961936565</udiDi>
    <basicUdiDi>B-04710961936565</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter</tradeName>
    <deviceName>Silicone 2-way Foley Balloon Catheter</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4822-0522</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:09:05.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961936558</udiDi>
    <basicUdiDi>B-04710961936558</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter</tradeName>
    <deviceName>Silicone 2-way Foley Balloon Catheter</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4822-0520</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:09:04.974Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961936541</udiDi>
    <basicUdiDi>B-04710961936541</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter</tradeName>
    <deviceName>Silicone 2-way Foley Balloon Catheter</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4822-0518</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:09:03.373Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961936534</udiDi>
    <basicUdiDi>B-04710961936534</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter</tradeName>
    <deviceName>Silicone 2-way Foley Balloon Catheter</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4822-0516</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:09:00.971Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961936527</udiDi>
    <basicUdiDi>B-04710961936527</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter</tradeName>
    <deviceName>Silicone 2-way Foley Balloon Catheter</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4822-0514</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:08:59.366Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961936510</udiDi>
    <basicUdiDi>B-04710961936510</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter</tradeName>
    <deviceName>Silicone 2-way Foley Balloon Catheter</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Silicone 2-way Foley Balloon Catheter</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:08:58.581Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961934202</udiDi>
    <basicUdiDi>B-04710961934202</basicUdiDi>
    <tradeName>Silicone Supra-Pubic Catheter</tradeName>
    <deviceName>Silicone Supra-Pubic Catheter</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U040102</emdnCode>
    <emdnDescription>KITS WITH DRAINAGE CATHETERS AND INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1890-8214</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:06:33.152Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961934196</udiDi>
    <basicUdiDi>B-04710961934196</basicUdiDi>
    <tradeName>Silicone Supra-Pubic Catheter</tradeName>
    <deviceName>Silicone Supra-Pubic Catheter</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U040102</emdnCode>
    <emdnDescription>KITS WITH DRAINAGE CATHETERS AND INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1890-8212</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:06:28.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961934134</udiDi>
    <basicUdiDi>B-04710961934134</basicUdiDi>
    <tradeName>Silicone Supra-Pubic Catheter</tradeName>
    <deviceName>Silicone Supra-Pubic Catheter</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U040199</emdnCode>
    <emdnDescription>DEVICES FOR SUPRAPUBIC URINARY DRAINAGE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1890-0214</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:06:27.524Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961933885</udiDi>
    <basicUdiDi>B-04710961933885</basicUdiDi>
    <tradeName>Silicone Hematuria Catheter, Couvelaire</tradeName>
    <deviceName>Silicone Hematuria Catheter, Couvelaire</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1865-0324</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:06:26.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961933878</udiDi>
    <basicUdiDi>B-04710961933878</basicUdiDi>
    <tradeName>Silicone Hematuria Catheter, Couvelaire</tradeName>
    <deviceName>Silicone Hematuria Catheter, Couvelaire</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1865-0322</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:06:25.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961933861</udiDi>
    <basicUdiDi>B-04710961933861</basicUdiDi>
    <tradeName>Silicone Hematuria Catheter, Couvelaire</tradeName>
    <deviceName>Silicone Hematuria Catheter, Couvelaire</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1865-0320</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:06:21.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961933854</udiDi>
    <basicUdiDi>B-04710961933854</basicUdiDi>
    <tradeName>Silicone Hematuria Catheter, Couvelaire</tradeName>
    <deviceName>Silicone Hematuria Catheter, Couvelaire</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1865-0318</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:06:21.121Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961933809</udiDi>
    <basicUdiDi>B-04710961933809</basicUdiDi>
    <tradeName>Silicone Hematuria Catheter, Dufour</tradeName>
    <deviceName>Silicone Hematuria Catheter, Dufour</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1864-0324</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:06:20.575Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961933793</udiDi>
    <basicUdiDi>B-04710961933793</basicUdiDi>
    <tradeName>Silicone Hematuria Catheter, Dufour</tradeName>
    <deviceName>Silicone Hematuria Catheter, Dufour</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1864-0322</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:06:19.650Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961933786</udiDi>
    <basicUdiDi>B-04710961933786</basicUdiDi>
    <tradeName>Silicone Hematuria Catheter, Dufour</tradeName>
    <deviceName>Silicone Hematuria Catheter, Dufour</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1864-0320</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:06:15.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961933779</udiDi>
    <basicUdiDi>B-04710961933779</basicUdiDi>
    <tradeName>Silicone Hematuria Catheter, Dufour</tradeName>
    <deviceName>Silicone Hematuria Catheter, Dufour</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1864-0318</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:06:14.725Z</lastUpdated>
  </row>
</eudamedExport>