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<eudamedExport entity="devices">
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    <udiDi>04710961937609</udiDi>
    <basicUdiDi>B-04710961937609</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>4890-0224</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:09:43.458Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961937593</udiDi>
    <basicUdiDi>B-04710961937593</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>4890-0222</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:09:42.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961937586</udiDi>
    <basicUdiDi>B-04710961937586</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>4890-0220</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:09:41.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961937579</udiDi>
    <basicUdiDi>B-04710961937579</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>4890-0218</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:09:41.070Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961937562</udiDi>
    <basicUdiDi>B-04710961937562</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>4890-0216</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:09:37.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961937555</udiDi>
    <basicUdiDi>B-04710961937555</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>4890-0214</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:09:36.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961937548</udiDi>
    <basicUdiDi>B-04710961937548</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>4890-0212</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:09:35.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961937135</udiDi>
    <basicUdiDi>B-04710961937135</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter Tiemann Tip</tradeName>
    <deviceName>Silicone 2-way Foley Balloon Catheter Tiemann Tip</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>4856-0222</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:09:34.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961937104</udiDi>
    <basicUdiDi>B-04710961937104</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter Tiemann Tip</tradeName>
    <deviceName>Silicone 2-way Foley Balloon Catheter Tiemann Tip</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>4856-0216</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:09:30.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961937128</udiDi>
    <basicUdiDi>B-04710961937128</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter Tiemann Tip</tradeName>
    <deviceName>Silicone 2-way Foley Balloon Catheter Tiemann Tip</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>4856-0220</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:09:29.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961937111</udiDi>
    <basicUdiDi>B-04710961937111</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter Tiemann Tip</tradeName>
    <deviceName>Silicone 2-way Foley Balloon Catheter Tiemann Tip</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>4856-0218</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:09:29.040Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961937098</udiDi>
    <basicUdiDi>B-04710961937098</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter Tiemann Tip</tradeName>
    <deviceName>Silicone 2-way Foley Balloon Catheter Tiemann Tip</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>4856-0214</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:09:28.260Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961937081</udiDi>
    <basicUdiDi>B-04710961937081</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter Tiemann Tip</tradeName>
    <deviceName>Silicone 2-way Foley Balloon Catheter Tiemann Tip</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>4856-0212</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:09:12.176Z</lastUpdated>
  </row>
  <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>
</eudamedExport>