<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>14711182606043</udiDi>
    <basicUdiDi>B-14711182606043</basicUdiDi>
    <tradeName>Silicone Hub-less Endo 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2015-0715</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T14:23:35.354Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182606050</udiDi>
    <basicUdiDi>B-14711182606050</basicUdiDi>
    <tradeName>Silicone Hub-less Endo 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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2015-0719</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T14:23:35.313Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961931703</udiDi>
    <basicUdiDi>B-14710961931703</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter</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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1821-0506</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T10:23:19.150Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961931710</udiDi>
    <basicUdiDi>B-14710961931710</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter</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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1821-0508</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T10:23:19.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961931727</udiDi>
    <basicUdiDi>B-14710961931727</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter</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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1821-0510</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T10:23:19.092Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961931871</udiDi>
    <basicUdiDi>B-14710961931871</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter</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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1822-0512</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T10:23:19.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961931888</udiDi>
    <basicUdiDi>B-14710961931888</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter</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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1822-0514</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T10:23:19.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961931895</udiDi>
    <basicUdiDi>B-14710961931895</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter</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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1822-0516</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T10:23:19.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961931901</udiDi>
    <basicUdiDi>B-14710961931901</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter</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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1822-0518</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T10:23:19.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961931918</udiDi>
    <basicUdiDi>B-14710961931918</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter</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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1822-0520</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T10:23:19.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961931925</udiDi>
    <basicUdiDi>B-14710961931925</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter</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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1822-0522</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T10:23:18.985Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961931932</udiDi>
    <basicUdiDi>B-14710961931932</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter</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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1822-0524</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T10:23:18.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961932175</udiDi>
    <basicUdiDi>B-14710961932175</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter</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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1823-0516</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T10:23:18.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961932380</udiDi>
    <basicUdiDi>B-14710961932380</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter, Female</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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1824-0514</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T10:23:18.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961932526</udiDi>
    <basicUdiDi>B-14710961932526</basicUdiDi>
    <tradeName>Silicone 3-way Foley Balloon Catheter</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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1830-0514</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T10:23:18.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>24711182605760</udiDi>
    <basicUdiDi>B-24711182605760</basicUdiDi>
    <tradeName>SILICONE VAC-DRAIN KIT,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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CO2014-9415</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-18T22:23:59.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>24711182605777</udiDi>
    <basicUdiDi>B-24711182605777</basicUdiDi>
    <tradeName>SILICONE VAC-DRAIN KIT,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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CO2014-9419</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-18T22:23:59.886Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182629366</udiDi>
    <basicUdiDi>B-04711182629366</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>CO2015-0208</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:09:25.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182629311</udiDi>
    <basicUdiDi>B-04711182629311</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>CO2015-9214</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:09:25.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182629298</udiDi>
    <basicUdiDi>B-04711182629298</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>2010-0419</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:09:23.211Z</lastUpdated>
  </row>
</eudamedExport>