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<eudamedExport entity="devices">
  <row>
    <udiDi>14711182608795</udiDi>
    <basicUdiDi>B-14711182608795</basicUdiDi>
    <tradeName>Silicone Vessel ID Loops</tradeName>
    <deviceName>Silicone Vessel ID Loops</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>V80</emdnCode>
    <emdnDescription>CLINICAL USE ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9005-0503R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:21:59.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182608702</udiDi>
    <basicUdiDi>B-14711182608702</basicUdiDi>
    <tradeName>Silicone Vessel ID Loops</tradeName>
    <deviceName>Silicone Vessel ID Loops</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>V80</emdnCode>
    <emdnDescription>CLINICAL USE ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9005-0503Y</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:21:58.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182608696</udiDi>
    <basicUdiDi>B-14711182608696</basicUdiDi>
    <tradeName>Silicone Vessel ID Loops</tradeName>
    <deviceName>Silicone Vessel ID Loops</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>V80</emdnCode>
    <emdnDescription>CLINICAL USE ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9005-0503W</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:21:54.836Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182608399</udiDi>
    <basicUdiDi>B-14711182608399</basicUdiDi>
    <tradeName>Silicone Gastrostomy Catheter with ENFit Connector</tradeName>
    <deviceName>Silicone Gastrostomy Catheter with ENFit Connector</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>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE588902</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:21:54.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182608382</udiDi>
    <basicUdiDi>B-14711182608382</basicUdiDi>
    <tradeName>Silicone Gastrostomy Catheter with ENFit Connector</tradeName>
    <deviceName>Silicone Gastrostomy Catheter with ENFit Connector</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>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2019-0518</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:21:53.212Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182608375</udiDi>
    <basicUdiDi>B-14711182608375</basicUdiDi>
    <tradeName>Silicone Gastrostomy Catheter with ENFit Connector</tradeName>
    <deviceName>Silicone Gastrostomy Catheter with ENFit Connector</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>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2019-0516</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:21:52.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182608191</udiDi>
    <basicUdiDi>B-14711182608191</basicUdiDi>
    <tradeName>silicone Clamp Jaw Cover</tradeName>
    <deviceName>silicone Clamp Jaw Cover</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>MDD</legislation>
    <emdnCode>H038099</emdnCode>
    <emdnDescription>CLIPS FOR HEMOSTASIS - ACCESSORIES OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9002-SR250</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:21:48.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182608184</udiDi>
    <basicUdiDi>B-14711182608184</basicUdiDi>
    <tradeName>silicone Clamp Jaw Cover</tradeName>
    <deviceName>silicone Clamp Jaw Cover</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>MDD</legislation>
    <emdnCode>H038099</emdnCode>
    <emdnDescription>CLIPS FOR HEMOSTASIS - ACCESSORIES OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9002-MW410</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:21:47.612Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182608368</udiDi>
    <basicUdiDi>B-14711182608368</basicUdiDi>
    <tradeName>Silicone Gastrostomy Catheter with ENFit Connector</tradeName>
    <deviceName>Silicone Gastrostomy Catheter with ENFit Connector</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>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2019-0514</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:21:46.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182608290</udiDi>
    <basicUdiDi>B-14711182608290</basicUdiDi>
    <tradeName>Silicone Round Drain System</tradeName>
    <deviceName>Silicone Round Drain System</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>A0601010102</emdnCode>
    <emdnDescription>DRAINAGE SYSTEMS WITH RESERVOIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0915-921840</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:21:46.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182608177</udiDi>
    <basicUdiDi>B-14711182608177</basicUdiDi>
    <tradeName>silicone Clamp Jaw Cover</tradeName>
    <deviceName>silicone Clamp Jaw Cover</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>MDD</legislation>
    <emdnCode>H038099</emdnCode>
    <emdnDescription>CLIPS FOR HEMOSTASIS - ACCESSORIES OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9002-LB570</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:21:29.161Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182608153</udiDi>
    <basicUdiDi>B-14711182608153</basicUdiDi>
    <tradeName>Rystora Silicone Scar Gel</tradeName>
    <deviceName>Rystora Silicone Scar Gel</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>MDD</legislation>
    <emdnCode>M0499</emdnCode>
    <emdnDescription>SPECIAL DRESSINGS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SGA01501</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:21:28.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182608108</udiDi>
    <basicUdiDi>B-14711182608108</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>4833-0518</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:21:27.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182608092</udiDi>
    <basicUdiDi>B-14711182608092</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>4833-0516</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:21:26.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182608085</udiDi>
    <basicUdiDi>B-14711182608085</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>4833-0514</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:21:22.750Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182608078</udiDi>
    <basicUdiDi>B-14711182608078</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>4833-0512</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:21:21.953Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182607989</udiDi>
    <basicUdiDi>B-14711182607989</basicUdiDi>
    <tradeName>"Fortune" FixPad Anchoring Device (Non-Sterile)</tradeName>
    <deviceName>"Fortune" FixPad Anchoring Device (Non-Sterile)</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>MDD</legislation>
    <emdnCode>V80</emdnCode>
    <emdnDescription>CLINICAL USE ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1800-0005</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:21:21.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182607958</udiDi>
    <basicUdiDi>B-14711182607958</basicUdiDi>
    <tradeName>Silicone Nasogastric Tube with ENFit Connector</tradeName>
    <deviceName>Silicone Nasogastric Tube with ENFit Connector</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>G02020101</emdnCode>
    <emdnDescription>NASOGASTRIC TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2020-0518</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:21:20.349Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182607941</udiDi>
    <basicUdiDi>B-14711182607941</basicUdiDi>
    <tradeName>Silicone Nasogastric Tube with ENFit Connector</tradeName>
    <deviceName>Silicone Nasogastric Tube with ENFit Connector</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>G02020101</emdnCode>
    <emdnDescription>NASOGASTRIC TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2020-0516</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:21:16.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182607934</udiDi>
    <basicUdiDi>B-14711182607934</basicUdiDi>
    <tradeName>Silicone Nasogastric Tube with ENFit Connector</tradeName>
    <deviceName>Silicone Nasogastric Tube with ENFit Connector</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>G02020101</emdnCode>
    <emdnDescription>NASOGASTRIC TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2020-0514</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:21:15.545Z</lastUpdated>
  </row>
</eudamedExport>