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<eudamedExport entity="devices">
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    <udiDi>04710961933625</udiDi>
    <basicUdiDi>B-04710961933625</basicUdiDi>
    <tradeName>Silicone 3-way Hematuria Catheter</tradeName>
    <deviceName>Silicone 3-way Hematuria 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>1862-0320</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:06:01.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961933618</udiDi>
    <basicUdiDi>B-04710961933618</basicUdiDi>
    <tradeName>Silicone 3-way Hematuria Catheter</tradeName>
    <deviceName>Silicone 3-way Hematuria 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>1862-0318</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:06:01.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961933564</udiDi>
    <basicUdiDi>B-04710961933564</basicUdiDi>
    <tradeName>Silicone 3-way Hematuria Catheter</tradeName>
    <deviceName>Silicone 3-way Hematuria 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>1861-0324</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:06:00.295Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961933557</udiDi>
    <basicUdiDi>B-04710961933557</basicUdiDi>
    <tradeName>Silicone 3-way Hematuria Catheter</tradeName>
    <deviceName>Silicone 3-way Hematuria 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>1861-0322</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:05:59.496Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961933540</udiDi>
    <basicUdiDi>B-04710961933540</basicUdiDi>
    <tradeName>Silicone 3-way Hematuria Catheter</tradeName>
    <deviceName>Silicone 3-way Hematuria 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>1861-0320</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:05:55.594Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961933533</udiDi>
    <basicUdiDi>B-04710961933533</basicUdiDi>
    <tradeName>Silicone 3-way Hematuria Catheter</tradeName>
    <deviceName>Silicone 3-way Hematuria 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>1861-0318</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:05:53.908Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961933397</udiDi>
    <basicUdiDi>B-04710961933397</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>1856-0222</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:05:53.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961933373</udiDi>
    <basicUdiDi>B-04710961933373</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>1856-0218</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:05:52.306Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961933366</udiDi>
    <basicUdiDi>B-04710961933366</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter Tiemann Tip</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1856-0216</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:03:50.873Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961933359</udiDi>
    <basicUdiDi>B-04710961933359</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter Tiemann Tip</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1856-0214</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:03:50.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961933342</udiDi>
    <basicUdiDi>B-04710961933342</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter Tiemann Tip</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1856-0212</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:03:50.759Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961933335</udiDi>
    <basicUdiDi>B-04710961933335</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>1856-0210</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:03:48.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961932581</udiDi>
    <basicUdiDi>B-04710961932581</basicUdiDi>
    <tradeName>Silicone 3-way Foley Balloon Catheter,Female</tradeName>
    <deviceName>Silicone 3-way Foley Balloon Catheter,Female</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>1830-0526</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:03:39.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961932574</udiDi>
    <basicUdiDi>B-04710961932574</basicUdiDi>
    <tradeName>Silicone 3-way Foley Balloon Catheter,Female</tradeName>
    <deviceName>Silicone 3-way Foley Balloon Catheter,Female</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>1830-0524</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:03:35.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961932567</udiDi>
    <basicUdiDi>B-04710961932567</basicUdiDi>
    <tradeName>Silicone 3-way Foley Balloon Catheter,Female</tradeName>
    <deviceName>Silicone 3-way Foley Balloon Catheter,Female</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>1830-0522</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:03:34.831Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961932550</udiDi>
    <basicUdiDi>B-04710961932550</basicUdiDi>
    <tradeName>Silicone 3-way Foley Balloon Catheter,Female</tradeName>
    <deviceName>Silicone 3-way Foley Balloon Catheter,Female</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>1830-0520</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:03:34.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961932543</udiDi>
    <basicUdiDi>B-04710961932543</basicUdiDi>
    <tradeName>Silicone 3-way Foley Balloon Catheter,Female</tradeName>
    <deviceName>Silicone 3-way Foley Balloon Catheter,Female</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>1830-0518</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:03:33.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961932383</udiDi>
    <basicUdiDi>B-04710961932383</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter,Female</tradeName>
    <deviceName>Silicone 2-way Foley Balloon Catheter,Female</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>1824-0514</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:03:29.263Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961932192</udiDi>
    <basicUdiDi>B-04710961932192</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>1823-0520</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:03:28.538Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961932185</udiDi>
    <basicUdiDi>B-04710961932185</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>1823-0518</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:03:13.181Z</lastUpdated>
  </row>
</eudamedExport>