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<eudamedExport entity="devices">
  <row>
    <udiDi>14711182605169</udiDi>
    <basicUdiDi>B-14711182605169</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>A0601010402</emdnCode>
    <emdnDescription>CYLINDRICAL OR CIRCULAR DRAINAGES (STRAIGHT AND T-SHAPED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PR2114-9405</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:17:09.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182605152</udiDi>
    <basicUdiDi>B-14711182605152</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>A0601010102</emdnCode>
    <emdnDescription>DRAINAGE SYSTEMS WITH RESERVOIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PR2114-9403</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:17:08.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182605138</udiDi>
    <basicUdiDi>B-14711182605138</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>PR2114-0405</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:17:08.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182605121</udiDi>
    <basicUdiDi>B-14711182605121</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>PR2114-0403</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:17:04.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182605053</udiDi>
    <basicUdiDi>B-14711182605053</basicUdiDi>
    <tradeName>Silicone Flat Drain Kit</tradeName>
    <deviceName>Silicone Flat 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>PR2014-9102</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:17:03.296Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182605046</udiDi>
    <basicUdiDi>B-14711182605046</basicUdiDi>
    <tradeName>Silicone Flat Drain Kit</tradeName>
    <deviceName>Silicone Flat 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>PR2014-9101</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:17:02.498Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182605039</udiDi>
    <basicUdiDi>B-14711182605039</basicUdiDi>
    <tradeName>Silicone Flat Drain Kit</tradeName>
    <deviceName>Silicone Flat 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>PR2014-9072</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:17:01.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182605015</udiDi>
    <basicUdiDi>B-14711182605015</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>PR2014-0132</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:16:57.698Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182605008</udiDi>
    <basicUdiDi>B-14711182605008</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>PR2014-0102</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:16:56.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182604995</udiDi>
    <basicUdiDi>B-14711182604995</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>PR2014-0101</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:16:56.095Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182604988</udiDi>
    <basicUdiDi>B-14711182604988</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>PR2014-0072</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:16:55.300Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182604971</udiDi>
    <basicUdiDi>B-14711182604971</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>PR2014-0071</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:16:51.293Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182604957</udiDi>
    <basicUdiDi>B-14711182604957</basicUdiDi>
    <tradeName>Silicone Penrose Drain Tube W/ Secure-Clip</tradeName>
    <deviceName>Silicone Penrose Drain Tube W/ Secure-Clip</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>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2010-6419</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:16:50.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182604940</udiDi>
    <basicUdiDi>B-14711182604940</basicUdiDi>
    <tradeName>Silicone Penrose Drain Tube W/ Secure-Clip</tradeName>
    <deviceName>Silicone Penrose Drain Tube W/ Secure-Clip</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>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2010-6415</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:16:49.698Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182604964</udiDi>
    <basicUdiDi>B-14711182604964</basicUdiDi>
    <tradeName>14711182604964</tradeName>
    <deviceName>Silicone Penrose Drain Tube W/ Secure-Clip</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>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2010-6425</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:16:48.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182604933</udiDi>
    <basicUdiDi>B-14711182604933</basicUdiDi>
    <tradeName>Silicone Penrose Drain Tube W/ Secure-Clip</tradeName>
    <deviceName>Silicone Penrose Drain Tube W/ Secure-Clip</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>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2010-6412</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:16:32.836Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182604926</udiDi>
    <basicUdiDi>B-14711182604926</basicUdiDi>
    <tradeName>Silicone Penrose Drain Tube W/ Secure-Clip</tradeName>
    <deviceName>Silicone Penrose Drain Tube W/ Secure-Clip</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>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2010-6410</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:16:30.441Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182604919</udiDi>
    <basicUdiDi>B-14711182604919</basicUdiDi>
    <tradeName>Silicone Penrose Drain Tube W/ Secure-Clip</tradeName>
    <deviceName>Silicone Penrose Drain Tube W/ Secure-Clip</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>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2010-6406</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:16:28.833Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182604902</udiDi>
    <basicUdiDi>B-14711182604902</basicUdiDi>
    <tradeName>Silicone Penrose Drain Tube W/ Secure-Clip</tradeName>
    <deviceName>Silicone Penrose Drain Tube W/ Secure-Clip</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>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2010-6406</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:16:28.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182604896</udiDi>
    <basicUdiDi>B-14711182604896</basicUdiDi>
    <tradeName>Silicone Penrose Drain Tube W/ Secure-Clip</tradeName>
    <deviceName>Silicone Penrose Drain Tube W/ Secure-Clip</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>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2010-6405</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:16:26.431Z</lastUpdated>
  </row>
</eudamedExport>