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<eudamedExport entity="devices">
  <row>
    <udiDi>04710961936039</udiDi>
    <basicUdiDi>B-04710961936039</basicUdiDi>
    <tradeName>Silicone Thoracic Drain, S Type</tradeName>
    <deviceName>Silicone Thoracic Drain, S Type</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>A0601010401</emdnCode>
    <emdnDescription>THORACIC DRAINAGES (STRAIGHT AND ANGLED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2018-0024</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:08:09.328Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961936008</udiDi>
    <basicUdiDi>B-04710961936008</basicUdiDi>
    <tradeName>Silicone Thoracic Drain, S Type</tradeName>
    <deviceName>Silicone Thoracic Drain, S Type</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>A0601010401</emdnCode>
    <emdnDescription>THORACIC DRAINAGES (STRAIGHT AND ANGLED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2018-0020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:08:08.524Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961935988</udiDi>
    <basicUdiDi>B-04710961935988</basicUdiDi>
    <tradeName>Silicone Thoracic Drain, S Type</tradeName>
    <deviceName>Silicone Thoracic Drain, S Type</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>A0601010401</emdnCode>
    <emdnDescription>THORACIC DRAINAGES (STRAIGHT AND ANGLED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Silicone Thoracic Drain, S Type</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:08:06.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961935803</udiDi>
    <basicUdiDi>B-04710961935803</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>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:07:55.737Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961935797</udiDi>
    <basicUdiDi>B-04710961935797</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>A0601010403</emdnCode>
    <emdnDescription>FLAT AND LAMELLAR DRAINAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2015-0619</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:07:54.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961935780</udiDi>
    <basicUdiDi>B-04710961935780</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>A0601010403</emdnCode>
    <emdnDescription>FLAT AND LAMELLAR DRAINAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2015-0615</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:07:51.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961935773</udiDi>
    <basicUdiDi>B-04710961935773</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>A0601010403</emdnCode>
    <emdnDescription>FLAT AND LAMELLAR DRAINAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2015-0610</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:07:50.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961935612</udiDi>
    <basicUdiDi>B-04710961935612</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>2015-9208</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:07:48.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961935551</udiDi>
    <basicUdiDi>B-04710961935551</basicUdiDi>
    <tradeName>Silicone Round Drain</tradeName>
    <deviceName>Silicone Round 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>2015-0208</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:07:46.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961935384</udiDi>
    <basicUdiDi>B-04710961935384</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>2014-9410</reference>
    <placedOnMarketCountry>Latvia</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:07:44.512Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961935049</udiDi>
    <basicUdiDi>B-04710961935049</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>2014-9052</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:07:42.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961935001</udiDi>
    <basicUdiDi>B-04710961935001</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>2014-0102</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:07:42.111Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961934981</udiDi>
    <basicUdiDi>B-04710961934981</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>2014-0072</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:07:40.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961934967</udiDi>
    <basicUdiDi>B-04710961934967</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>2014-0052</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:07:38.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961934912</udiDi>
    <basicUdiDi>B-04710961934912</basicUdiDi>
    <tradeName>Silicone C.W.V. Reservoir</tradeName>
    <deviceName>Silicone C.W.V. Reservoir</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>A0601010199</emdnCode>
    <emdnDescription>DRAINAGE SYSTEMS WITH PREDEFINED SUCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2013-0940</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:07:36.506Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961934905</udiDi>
    <basicUdiDi>B-04710961934905</basicUdiDi>
    <tradeName>Silicone C.W.V. Reservoir</tradeName>
    <deviceName>Silicone C.W.V. Reservoir</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>A0601010199</emdnCode>
    <emdnDescription>DRAINAGE SYSTEMS WITH PREDEFINED SUCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2013-0920</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:07:35.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961934899</udiDi>
    <basicUdiDi>B-04710961934899</basicUdiDi>
    <tradeName>Silicone C.W.V. Reservoir</tradeName>
    <deviceName>Silicone C.W.V. Reservoir</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>A0601010199</emdnCode>
    <emdnDescription>DRAINAGE SYSTEMS WITH PREDEFINED SUCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2013-0915</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:07:34.111Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961934882</udiDi>
    <basicUdiDi>B-04710961934882</basicUdiDi>
    <tradeName>Silicone C.W.V. Reservoir</tradeName>
    <deviceName>Silicone C.W.V. Reservoir</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>A0601010199</emdnCode>
    <emdnDescription>DRAINAGE SYSTEMS WITH PREDEFINED SUCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2013-0910</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:07:31.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961934776</udiDi>
    <basicUdiDi>B-04710961934776</basicUdiDi>
    <tradeName>Silicone Penrose Straight Drain Tube</tradeName>
    <deviceName>Silicone Penrose Straight 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>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2011-0035</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:07:30.095Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961934769</udiDi>
    <basicUdiDi>B-04710961934769</basicUdiDi>
    <tradeName>Silicone Penrose Straight Drain Tube</tradeName>
    <deviceName>Silicone Penrose Straight 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>A06010199</emdnCode>
    <emdnDescription>VACUUM AND GRAVITY DRAINAGE SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2011-0025</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T08:07:29.298Z</lastUpdated>
  </row>
</eudamedExport>