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<eudamedExport entity="devices">
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    <udiDi>14711182606128</udiDi>
    <basicUdiDi>B-14711182606128</basicUdiDi>
    <tradeName>Fortune®Silicone Hub-less Endo Drain Kit</tradeName>
    <deviceName>Fortune®Silicone Hub-less Endo Drain Kit</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>MDD</legislation>
    <emdnCode>A0601010403</emdnCode>
    <emdnDescription>FLAT AND LAMELLAR DRAINAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2015-9719</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:20:11.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182606111</udiDi>
    <basicUdiDi>B-14711182606111</basicUdiDi>
    <tradeName>Fortune®Silicone Hub-less Endo Drain Kit</tradeName>
    <deviceName>Fortune®Silicone Hub-less Endo Drain Kit</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>MDD</legislation>
    <emdnCode>A0601010403</emdnCode>
    <emdnDescription>FLAT AND LAMELLAR DRAINAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2015-9715</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:20:10.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182606104</udiDi>
    <basicUdiDi>B-14711182606104</basicUdiDi>
    <tradeName>Silicone Hub-less Endo Drain Kit</tradeName>
    <deviceName>Silicone Hub-less Endo Drain Kit</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>MDD</legislation>
    <emdnCode>A0601010403</emdnCode>
    <emdnDescription>FLAT AND LAMELLAR DRAINAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A0601010403</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:20:09.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182606098</udiDi>
    <basicUdiDi>B-14711182606098</basicUdiDi>
    <tradeName>Silicone Hub-less Endo Drain Tube</tradeName>
    <deviceName>Silicone Hub-less Endo Drain Tube</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>MDD</legislation>
    <emdnCode>A0601010402</emdnCode>
    <emdnDescription>CYLINDRICAL OR CIRCULAR DRAINAGES (STRAIGHT AND T-SHAPED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2015-0729</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:20:05.847Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182606081</udiDi>
    <basicUdiDi>B-14711182606081</basicUdiDi>
    <tradeName>Silicone Hub-less Endo Drain Tube</tradeName>
    <deviceName>Silicone Hub-less Endo Drain Tube</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>MDD</legislation>
    <emdnCode>A0601010402</emdnCode>
    <emdnDescription>CYLINDRICAL OR CIRCULAR DRAINAGES (STRAIGHT AND T-SHAPED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2015-0724</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:20:05.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182606050</udiDi>
    <basicUdiDi>B-14711182606050</basicUdiDi>
    <tradeName>Silicone Hub-less Endo Drain Tube</tradeName>
    <deviceName>Silicone Hub-less Endo Drain Tube</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>MDD</legislation>
    <emdnCode>A0601010402</emdnCode>
    <emdnDescription>CYLINDRICAL OR CIRCULAR DRAINAGES (STRAIGHT AND T-SHAPED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2015-0719</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:20:04.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182606043</udiDi>
    <basicUdiDi>B-14711182606043</basicUdiDi>
    <tradeName>Silicone Hub-less Endo Drain Tube</tradeName>
    <deviceName>Silicone Hub-less Endo Drain Tube</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>MDD</legislation>
    <emdnCode>A0601010402</emdnCode>
    <emdnDescription>CYLINDRICAL OR CIRCULAR DRAINAGES (STRAIGHT AND T-SHAPED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2015-0715</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:20:03.450Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182606036</udiDi>
    <basicUdiDi>B-14711182606036</basicUdiDi>
    <tradeName>Silicone Hub-less Endo Drain Tube</tradeName>
    <deviceName>Silicone Hub-less Endo Drain Tube</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>MDD</legislation>
    <emdnCode>A0601010402</emdnCode>
    <emdnDescription>CYLINDRICAL OR CIRCULAR DRAINAGES (STRAIGHT AND T-SHAPED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2015-0710</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:19:59.438Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182605770</udiDi>
    <basicUdiDi>B-14711182605770</basicUdiDi>
    <tradeName>SILICONE VAC-DRAIN KIT,ROUND</tradeName>
    <deviceName>SILICONE VAC-DRAIN KIT,ROUND</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>MDD</legislation>
    <emdnCode>A0601010403</emdnCode>
    <emdnDescription>FLAT AND LAMELLAR DRAINAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CO2014-9419</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:19:58.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182605763</udiDi>
    <basicUdiDi>B-14711182605763</basicUdiDi>
    <tradeName>SILICONE VAC-DRAIN KIT,ROUND</tradeName>
    <deviceName>SILICONE VAC-DRAIN KIT,ROUND</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>MDD</legislation>
    <emdnCode>A0601010403</emdnCode>
    <emdnDescription>FLAT AND LAMELLAR DRAINAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SILICONE VAC-DRAIN KIT,ROUND</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:19:57.831Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182605732</udiDi>
    <basicUdiDi>B-14711182605732</basicUdiDi>
    <tradeName>Silicone Round Drain Kit</tradeName>
    <deviceName>Silicone Round Drain Kit</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>MDD</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>2026-07-11T05:19:57.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182605725</udiDi>
    <basicUdiDi>B-14711182605725</basicUdiDi>
    <tradeName>Silicone Round Drain Kit</tradeName>
    <deviceName>Silicone Round Drain Kit</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>MDD</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>2026-07-11T05:19:53.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182605718</udiDi>
    <basicUdiDi>B-14711182605718</basicUdiDi>
    <tradeName>Silicone Round Drain Kit</tradeName>
    <deviceName>Silicone Round Drain Kit</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>MDD</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>2026-07-11T05:19:52.226Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182605695</udiDi>
    <basicUdiDi>B-14711182605695</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>MDD</legislation>
    <emdnCode>A0601010403</emdnCode>
    <emdnDescription>FLAT AND LAMELLAR DRAINAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CO2014-0071</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:19:51.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182605688</udiDi>
    <basicUdiDi>B-14711182605688</basicUdiDi>
    <tradeName>Silicone Flat Drain</tradeName>
    <deviceName>Silicone Flat Drain</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>MDD</legislation>
    <emdnCode>A0601010403</emdnCode>
    <emdnDescription>FLAT AND LAMELLAR DRAINAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CO2014-0132</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:19:50.626Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182605671</udiDi>
    <basicUdiDi>B-14711182605671</basicUdiDi>
    <tradeName>Silicone Flat Drain</tradeName>
    <deviceName>Silicone Flat Drain</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>MDD</legislation>
    <emdnCode>A0601010403</emdnCode>
    <emdnDescription>FLAT AND LAMELLAR DRAINAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CO2014-0102</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:19:46.619Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182605664</udiDi>
    <basicUdiDi>B-14711182605664</basicUdiDi>
    <tradeName>Silicone Flat Drain</tradeName>
    <deviceName>Silicone Flat Drain</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>MDD</legislation>
    <emdnCode>A0601010403</emdnCode>
    <emdnDescription>FLAT AND LAMELLAR DRAINAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CO2014-0072</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:19:45.835Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182605527</udiDi>
    <basicUdiDi>B-14711182605527</basicUdiDi>
    <tradeName>Silicone Endo Drain</tradeName>
    <deviceName>Silicone Endo Drain</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>MDD</legislation>
    <emdnCode>A0601010402</emdnCode>
    <emdnDescription>CYLINDRICAL OR CIRCULAR DRAINAGES (STRAIGHT AND T-SHAPED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2015-0621</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:19:44.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182605312</udiDi>
    <basicUdiDi>B-14711182605312</basicUdiDi>
    <tradeName>Silicone Vac Drain, Round</tradeName>
    <deviceName>Silicone Vac Drain, Round</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>MDD</legislation>
    <emdnCode>A0601010403</emdnCode>
    <emdnDescription>FLAT AND LAMELLAR DRAINAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CO2014-0415</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:17:22.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182605305</udiDi>
    <basicUdiDi>B-14711182605305</basicUdiDi>
    <tradeName>Silicone Round Drain Kit</tradeName>
    <deviceName>Silicone Round Drain Kit</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>MDD</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>2026-07-11T05:17:21.710Z</lastUpdated>
  </row>
</eudamedExport>