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<eudamedExport entity="devices">
  <row>
    <udiDi>04711182605735</udiDi>
    <basicUdiDi>B-04711182605735</basicUdiDi>
    <tradeName>Silicone Round Drain Kit</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0601010402</emdnCode>
    <emdnDescription>CYLINDRICAL OR CIRCULAR DRAINAGES (STRAIGHT AND T-SHAPED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CO2015-9218</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:06:39.008Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182605728</udiDi>
    <basicUdiDi>B-04711182605728</basicUdiDi>
    <tradeName>Silicone Round Drain Kit</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0601010402</emdnCode>
    <emdnDescription>CYLINDRICAL OR CIRCULAR DRAINAGES (STRAIGHT AND T-SHAPED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CO2015-9216</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:06:37.189Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182605711</udiDi>
    <basicUdiDi>B-04711182605711</basicUdiDi>
    <tradeName>Silicone Round Drain Kit</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0601010402</emdnCode>
    <emdnDescription>CYLINDRICAL OR CIRCULAR DRAINAGES (STRAIGHT AND T-SHAPED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CO2015-9210</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:06:36.311Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182605704</udiDi>
    <basicUdiDi>B-04711182605704</basicUdiDi>
    <tradeName>Silicone Round Drain Tube</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0601010402</emdnCode>
    <emdnDescription>CYLINDRICAL OR CIRCULAR DRAINAGES (STRAIGHT AND T-SHAPED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CO2015-0218</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:06:34.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182605698</udiDi>
    <basicUdiDi>B-04711182605698</basicUdiDi>
    <tradeName>Silicone Flat Drain</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0601010403</emdnCode>
    <emdnDescription>FLAT AND LAMELLAR DRAINAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CO2014-0071</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:06:33.595Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182605681</udiDi>
    <basicUdiDi>B-04711182605681</basicUdiDi>
    <tradeName>Silicone Flat Drain</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0601010403</emdnCode>
    <emdnDescription>FLAT AND LAMELLAR DRAINAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CO2014-0132</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:06:31.782Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182605674</udiDi>
    <basicUdiDi>B-04711182605674</basicUdiDi>
    <tradeName>Silicone Flat Drain</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0601010403</emdnCode>
    <emdnDescription>FLAT AND LAMELLAR DRAINAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CO2014-0102</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:06:30.866Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182605667</udiDi>
    <basicUdiDi>B-04711182605667</basicUdiDi>
    <tradeName>Silicone Flat Drain</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0601010403</emdnCode>
    <emdnDescription>FLAT AND LAMELLAR DRAINAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CO2014-0072</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:06:29.066Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182605568</udiDi>
    <basicUdiDi>B-04711182605568</basicUdiDi>
    <tradeName>Silicone Penrose Drain Tube</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2010-0415</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:06:26.381Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182605520</udiDi>
    <basicUdiDi>B-04711182605520</basicUdiDi>
    <tradeName>Silicone Endo Drain</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0601010402</emdnCode>
    <emdnDescription>CYLINDRICAL OR CIRCULAR DRAINAGES (STRAIGHT AND T-SHAPED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2015-0624</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:06:25.470Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182605483</udiDi>
    <basicUdiDi>471096193111201FG</basicUdiDi>
    <tradeName>Silicone Nasal Epistaxis Balloon</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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q030201</emdnCode>
    <emdnDescription>EPISTAXIS CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3103-0930</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:06:23.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182605476</udiDi>
    <basicUdiDi>471096193111201FG</basicUdiDi>
    <tradeName>04711182605476</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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q030201</emdnCode>
    <emdnDescription>EPISTAXIS CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3101-0830</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:06:22.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182605445</udiDi>
    <basicUdiDi>B-04711182605445</basicUdiDi>
    <tradeName>Silicone Penrose Drain Tube</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2010-1425</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:06:20.064Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182605438</udiDi>
    <basicUdiDi>B-04711182605438</basicUdiDi>
    <tradeName>Silicone Penrose Drain Tube</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2010-1419</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:06:18.260Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182605353</udiDi>
    <basicUdiDi>47109619304020103AS</basicUdiDi>
    <tradeName>ENDO CONNECTOR</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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0680</emdnCode>
    <emdnDescription>DRAINAGE AND FLUID COLLECTION DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2015-8601</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:06:17.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182605315</udiDi>
    <basicUdiDi>B-04711182605315</basicUdiDi>
    <tradeName>Silicone Vac Drain, Round</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0601010403</emdnCode>
    <emdnDescription>FLAT AND LAMELLAR DRAINAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CO2014-0415</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:06:15.573Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182605308</udiDi>
    <basicUdiDi>B-04711182605308</basicUdiDi>
    <tradeName>Silicone Round Drain Kit</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0601010402</emdnCode>
    <emdnDescription>CYLINDRICAL OR CIRCULAR DRAINAGES (STRAIGHT AND T-SHAPED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CO2015-9220</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:06:14.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182605292</udiDi>
    <basicUdiDi>B-04711182605292</basicUdiDi>
    <tradeName>Silicone Round Drain Tube</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0601010402</emdnCode>
    <emdnDescription>CYLINDRICAL OR CIRCULAR DRAINAGES (STRAIGHT AND T-SHAPED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CO2015-0220</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:06:12.867Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182605285</udiDi>
    <basicUdiDi>B-04711182605285</basicUdiDi>
    <tradeName>Silicone Round Drain Tube</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0601010402</emdnCode>
    <emdnDescription>CYLINDRICAL OR CIRCULAR DRAINAGES (STRAIGHT AND T-SHAPED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CO2015-0216</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:06:11.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182605278</udiDi>
    <basicUdiDi>B-04711182605278</basicUdiDi>
    <tradeName>Silicone Round Drain Tube</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0601010402</emdnCode>
    <emdnDescription>CYLINDRICAL OR CIRCULAR DRAINAGES (STRAIGHT AND T-SHAPED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CO2015-0214</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:06:10.159Z</lastUpdated>
  </row>
</eudamedExport>