<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04711182604905</udiDi>
    <basicUdiDi>B-04711182604905</basicUdiDi>
    <tradeName>Silicone Penrose Drain Tube W/ Secure-Clip</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>2010-6406</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:05:34.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182604899</udiDi>
    <basicUdiDi>B-04711182604899</basicUdiDi>
    <tradeName>Silicone Penrose Drain Tube W/ Secure-Clip</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>2010-6405</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:05:32.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182604851</udiDi>
    <basicUdiDi>B-04711182604851</basicUdiDi>
    <tradeName>Silicone Penrose Drain Tube W/ Secure-Clip</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>2010-5412</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:05:31.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182604837</udiDi>
    <basicUdiDi>B-04711182604837</basicUdiDi>
    <tradeName>Silicone Penrose Drain Tube W/ Secure-Clip</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>2010-5408</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:05:29.869Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182604561</udiDi>
    <basicUdiDi>B-04711182604561</basicUdiDi>
    <tradeName>Guedel Airway</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>R010102</emdnCode>
    <emdnDescription>GUEDEL AIRWAY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1603-0090</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:05:28.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182604202</udiDi>
    <basicUdiDi>B-04711182604202</basicUdiDi>
    <tradeName>Silicone Vac Drain,Flat</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>CO2014-0408</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:05:27.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182604004</udiDi>
    <basicUdiDi>B-04711182604004</basicUdiDi>
    <tradeName>Silicone Birth Vac Cup</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>Z12080301</emdnCode>
    <emdnDescription>OBSTETRIC VACUUM EXTRACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300-0050</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:05:26.247Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182603151</udiDi>
    <basicUdiDi>B-04711182603151</basicUdiDi>
    <tradeName>"Fortune" Laryngeal Mask Tube (Non-Sterile)</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>R01020101</emdnCode>
    <emdnDescription>LARYNGEAL MASKS, SINGLE-LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1580-0050</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:05:24.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182603144</udiDi>
    <basicUdiDi>B-04711182603144</basicUdiDi>
    <tradeName>"Fortune" Laryngeal Mask Tube (Non-Sterile)</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>R01020101</emdnCode>
    <emdnDescription>LARYNGEAL MASKS, SINGLE-LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1580-0040</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:05:23.552Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182603137</udiDi>
    <basicUdiDi>B-04711182603137</basicUdiDi>
    <tradeName>"Fortune" Laryngeal Mask Tube (Non-Sterile)</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>R01020101</emdnCode>
    <emdnDescription>LARYNGEAL MASKS, SINGLE-LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1580-0030</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:05:21.736Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182603120</udiDi>
    <basicUdiDi>B-04711182603120</basicUdiDi>
    <tradeName>"Fortune" Laryngeal Mask Tube (Non-Sterile)</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>R01020101</emdnCode>
    <emdnDescription>LARYNGEAL MASKS, SINGLE-LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1580-0025</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:05:20.833Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182603113</udiDi>
    <basicUdiDi>B-04711182603113</basicUdiDi>
    <tradeName>"Fortune" Laryngeal Mask Tube (Non-Sterile)</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>R01020101</emdnCode>
    <emdnDescription>LARYNGEAL MASKS, SINGLE-LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1580-0020</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:05:19.054Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182603106</udiDi>
    <basicUdiDi>B-04711182603106</basicUdiDi>
    <tradeName>"Fortune" Laryngeal Mask Tube (Non-Sterile)</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>R01020101</emdnCode>
    <emdnDescription>LARYNGEAL MASKS, SINGLE-LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1580-0015</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:05:18.167Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182603083</udiDi>
    <basicUdiDi>B-04711182603083</basicUdiDi>
    <tradeName>Fortune Silicone Gastroplasty Calibration 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>G020502</emdnCode>
    <emdnDescription>GASTRIC CALIBRATION TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2170-3039</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:05:16.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182603052</udiDi>
    <basicUdiDi>B-04711182603052</basicUdiDi>
    <tradeName>Teeth Opener</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>R030280</emdnCode>
    <emdnDescription>RESPIRATORY BALLONS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1607-9001</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:05:15.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961937821</udiDi>
    <basicUdiDi>B-04710961937821</basicUdiDi>
    <tradeName>Silicone Flat 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>A0601010403</emdnCode>
    <emdnDescription>FLAT AND LAMELLAR DRAINAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CO2014-9072</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:02:56.149Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961937692</udiDi>
    <basicUdiDi>B-04710961937692</basicUdiDi>
    <tradeName>Silicone Supra-Pubic Catheter Puncture Set</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>U040101</emdnCode>
    <emdnDescription>KITS WITH DRAINAGE CATHETERS, DIRECT PUNCTURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4890-9214</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:02:54.330Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961937654</udiDi>
    <basicUdiDi>B-04710961937654</basicUdiDi>
    <tradeName>Silicone Supra-Pubic Catheter Exchange Set</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>U040102</emdnCode>
    <emdnDescription>KITS WITH DRAINAGE CATHETERS AND INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4890-8220</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:02:45.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961937647</udiDi>
    <basicUdiDi>B-04710961937647</basicUdiDi>
    <tradeName>Silicone Supra-Pubic Catheter Exchange Set</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>U040102</emdnCode>
    <emdnDescription>KITS WITH DRAINAGE CATHETERS AND INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4890-8218</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:02:44.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961937630</udiDi>
    <basicUdiDi>B-04710961937630</basicUdiDi>
    <tradeName>Silicone Supra-Pubic Catheter Exchange Set</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>U040102</emdnCode>
    <emdnDescription>KITS WITH DRAINAGE CATHETERS AND INTRODUCERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4890-8216</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:02:42.819Z</lastUpdated>
  </row>
</eudamedExport>