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    <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>14711182604209</udiDi>
    <basicUdiDi>B-14711182604209</basicUdiDi>
    <tradeName>Silicone Vac Drain,Flat</tradeName>
    <deviceName>Silicone Vac Drain,Flat</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>CO2014-0408</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:16:20.833Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961937828</udiDi>
    <basicUdiDi>B-14710961937828</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>CO2014-9102</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:16:07.220Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961935794</udiDi>
    <basicUdiDi>B-14710961935794</basicUdiDi>
    <tradeName>A0601010403</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>2026-07-11T05:13:56.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961935787</udiDi>
    <basicUdiDi>B-14710961935787</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>2026-07-11T05:13:55.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961935770</udiDi>
    <basicUdiDi>B-14710961935770</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>2015-0621</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:13:54.936Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961935381</udiDi>
    <basicUdiDi>B-14710961935381</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>2026-07-11T05:13:50.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961935046</udiDi>
    <basicUdiDi>B-14710961935046</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>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:13:49.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961935008</udiDi>
    <basicUdiDi>B-14710961935008</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>2026-07-11T05:13:30.851Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961934988</udiDi>
    <basicUdiDi>B-14710961934988</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>2026-07-11T05:13:30.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961934964</udiDi>
    <basicUdiDi>B-14710961934964</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>2026-07-11T05:13:29.267Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698573037879</udiDi>
    <basicUdiDi>B-08698573037879</basicUdiDi>
    <tradeName>PLASTİ-MED</tradeName>
    <deviceName>SOFT DRAIN 28 CH W/ DRAINAGE BAG SILICONE</deviceName>
    <manufacturerName>Plasti-med Plastik Medikal Ürünler San. ve Tic. Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000032251</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0601010403</emdnCode>
    <emdnDescription>FLAT AND LAMELLAR DRAINAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>103 828</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T04:41:04.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698573037862</udiDi>
    <basicUdiDi>B-08698573037862</basicUdiDi>
    <tradeName>PLASTİ-MED</tradeName>
    <deviceName>SOFT DRAIN 24 CH W/ DRAINAGE BAG SILICONE</deviceName>
    <manufacturerName>Plasti-med Plastik Medikal Ürünler San. ve Tic. Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000032251</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0601010403</emdnCode>
    <emdnDescription>FLAT AND LAMELLAR DRAINAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>103 824</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T04:41:04.046Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698573037787</udiDi>
    <basicUdiDi>B-08698573037787</basicUdiDi>
    <tradeName>PLASTİ-MED</tradeName>
    <deviceName>SOFT DRAIN 30 CH W/ DRAINAGE BAG SILICONE</deviceName>
    <manufacturerName>Plasti-med Plastik Medikal Ürünler San. ve Tic. Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000032251</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0601010403</emdnCode>
    <emdnDescription>FLAT AND LAMELLAR DRAINAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>103 830</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T04:40:52.836Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698573037763</udiDi>
    <basicUdiDi>B-08698573037763</basicUdiDi>
    <tradeName>PLASTİ-MED</tradeName>
    <deviceName>FLAT DRAIN 13 mm</deviceName>
    <manufacturerName>Plasti-med Plastik Medikal Ürünler San. ve Tic. Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000032251</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0601010403</emdnCode>
    <emdnDescription>FLAT AND LAMELLAR DRAINAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>103713</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T04:40:52.037Z</lastUpdated>
  </row>
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