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<eudamedExport entity="devices">
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    <udiDi>04714127860220</udiDi>
    <basicUdiDi>B-04714127860220</basicUdiDi>
    <tradeName>04714127860220</tradeName>
    <deviceName>DERBY YANKAUER SUCKER</deviceName>
    <manufacturerName>Unimax Medical Systems Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000008895</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A06010103</emdnCode>
    <emdnDescription>CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AEYS3014</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:33:40.825Z</lastUpdated>
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    <udiDi>04710961936206</udiDi>
    <basicUdiDi>B-04710961936206</basicUdiDi>
    <tradeName>Silicone Thoracic Drain, RF Type</tradeName>
    <deviceName>Silicone Thoracic Drain, RF 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>2018-0524</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:33:33.620Z</lastUpdated>
  </row>
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    <udiDi>04710961936084</udiDi>
    <basicUdiDi>B-04710961936084</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>2018-0033</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:33:32.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961936015</udiDi>
    <basicUdiDi>B-04710961936015</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>2018-0021</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:33:28.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941165059943</udiDi>
    <basicUdiDi>69411650000000297F</basicUdiDi>
    <tradeName>06941165059943</tradeName>
    <deviceName>Disposable Drainage Catheters</deviceName>
    <manufacturerName>Suzhou Leapmed Healthcare Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000013964</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A06010103</emdnCode>
    <emdnDescription>CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LZ6F-15</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:40:17.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182629236</udiDi>
    <basicUdiDi>B-04711182629236</basicUdiDi>
    <tradeName>C.W.V. Reservoir, bottom outlet+Collection Bag</tradeName>
    <deviceName>C.W.V. Reservoir, bottom outlet+Collection Bag</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>2013-091040</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:40:02.528Z</lastUpdated>
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  <row>
    <udiDi>04711182613051</udiDi>
    <basicUdiDi>B-04711182613051</basicUdiDi>
    <tradeName>Silicone T Drainage Set</tradeName>
    <deviceName>Silicone T Drainage Set</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>1910-8012</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:39:58.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182613044</udiDi>
    <basicUdiDi>B-04711182613044</basicUdiDi>
    <tradeName>Silicone T Drainage Set</tradeName>
    <deviceName>Silicone T Drainage Set</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>1910-8014</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:39:57.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182613020</udiDi>
    <basicUdiDi>B-04711182613020</basicUdiDi>
    <tradeName>Silicone T Drainage Set</tradeName>
    <deviceName>Silicone T Drainage Set</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>1910-8018</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:39:56.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182613006</udiDi>
    <basicUdiDi>B-04711182613006</basicUdiDi>
    <tradeName>Silicone T Drainage Set</tradeName>
    <deviceName>Silicone T Drainage Set</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>1910-8022</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:39:56.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182607548</udiDi>
    <basicUdiDi>B-04711182607548</basicUdiDi>
    <tradeName>Silicone T Drainage Set</tradeName>
    <deviceName>Silicone T Drainage Set</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>1910-8212</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:39:52.119Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182606657</udiDi>
    <basicUdiDi>B-04711182606657</basicUdiDi>
    <tradeName>Silicone Penrose Drain Tube</tradeName>
    <deviceName>Silicone Penrose 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>2010-1415</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:39:51.310Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182606640</udiDi>
    <basicUdiDi>B-04711182606640</basicUdiDi>
    <tradeName>Fortune®Silicone Hubless Endo Drain Kit ( Trocar + J Connector )</tradeName>
    <deviceName>Fortune®Silicone Hubless Endo Drain Kit ( Trocar + J Connector )</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>2015-9719J</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:39:50.528Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182606633</udiDi>
    <basicUdiDi>B-04711182606633</basicUdiDi>
    <tradeName>Fortune®Silicone Hubless Endo Drain Kit ( Trocar + J Connector )</tradeName>
    <deviceName>Fortune®Silicone Hubless Endo Drain Kit ( Trocar + J Connector )</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>2015-9715J</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:39:49.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182604875</udiDi>
    <basicUdiDi>B-04711182604875</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>2010-5419</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:39:45.708Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182604868</udiDi>
    <basicUdiDi>B-04711182604868</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>2010-5415</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:39:44.927Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182606459</udiDi>
    <basicUdiDi>B-04711182606459</basicUdiDi>
    <tradeName>Silicone Hubless Endo Drain Kit(Bendable Trocar + J Connector)</tradeName>
    <deviceName>Silicone Hubless Endo Drain Kit(Bendable Trocar + J Connector)</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>2015-9715JB</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:39:44.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182604882</udiDi>
    <basicUdiDi>B-04711182604882</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>2010-5419</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:39:43.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182604844</udiDi>
    <basicUdiDi>B-04711182604844</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>2010-5410</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:39:26.458Z</lastUpdated>
  </row>
  <row>
    <udiDi>04711182604820</udiDi>
    <basicUdiDi>B-04711182604820</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>2010-5406</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:39:25.661Z</lastUpdated>
  </row>
</eudamedExport>