<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08699412332247</udiDi>
    <basicUdiDi>B-08699412332247</basicUdiDi>
    <tradeName>PLASTI-MED</tradeName>
    <deviceName>HYDROPHILIC NITINOL PTFE GUIDEWIRE 0.038" 150 cm</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>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>536024</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T14:29:42.289Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699412332230</udiDi>
    <basicUdiDi>B-08699412332230</basicUdiDi>
    <tradeName>PLASTI-MED</tradeName>
    <deviceName>HYDROPHILIC NITINOL PTFE GUIDEWIRE 0.035" 150 cm</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>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>536023</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T14:29:41.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699412332186</udiDi>
    <basicUdiDi>B-08699412332186</basicUdiDi>
    <tradeName>PLASTI-MED</tradeName>
    <deviceName>OCEAN™ NITINOL GUIDE WIRE 0.038" 150 cm</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>U0699</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>536018</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T14:29:37.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699412332179</udiDi>
    <basicUdiDi>B-08699412332179</basicUdiDi>
    <tradeName>PLASTI-MED</tradeName>
    <deviceName>OCEAN™ NITINOL GUIDE WIRE 0.035" 150 cm</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>U0699</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>536017</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T14:29:36.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699412332162</udiDi>
    <basicUdiDi>B-08699412332162</basicUdiDi>
    <tradeName>PLASTI-MED</tradeName>
    <deviceName>OCEAN™ NITINOL GUIDE WIRE 0.032" 150 cm</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>U0699</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>536016</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T14:29:35.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699412332124</udiDi>
    <basicUdiDi>B-08699412332124</basicUdiDi>
    <tradeName>PLASTI-MED</tradeName>
    <deviceName>HYDROPHILIC NITINOL GUIDE WIRE 0.038" 150 cm ANGLED</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>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>536012</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T14:29:35.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699412332117</udiDi>
    <basicUdiDi>B-08699412332117</basicUdiDi>
    <tradeName>PLASTI-MED</tradeName>
    <deviceName>HYDROPHILIC NITINOL GUIDE WIRE 0.035" 150 cm ANGLED</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>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>536011</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T14:29:31.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699412332100</udiDi>
    <basicUdiDi>B-08699412332100</basicUdiDi>
    <tradeName>PLASTI-MED</tradeName>
    <deviceName>HYDROPHILIC NITINOL GUIDE WIRE 0.032" 150 cm ANGLED</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>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>536010</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T14:29:30.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699412332063</udiDi>
    <basicUdiDi>B-08699412332063</basicUdiDi>
    <tradeName>PLASTI-MED</tradeName>
    <deviceName>HYDROPHILIC NITINOL GUIDE WIRE 0.038" 150 cm STRAIGHT TIP</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>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>536006</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T14:29:29.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699412332056</udiDi>
    <basicUdiDi>B-08699412332056</basicUdiDi>
    <tradeName>PLASTI-MED</tradeName>
    <deviceName>HYDROPHILIC NITINOL GUIDE WIRE 0.035" 150 cm STRAIGHT TIP</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>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>536005</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T14:29:28.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699412332049</udiDi>
    <basicUdiDi>B-08699412332049</basicUdiDi>
    <tradeName>PLASTI-MED</tradeName>
    <deviceName>HYDROPHILIC NITINOL GUIDE WIRE 0.032" 150 cm STRAIGHT TIP</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>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>536004</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T14:28:14.787Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699412332032</udiDi>
    <basicUdiDi>B-08699412332032</basicUdiDi>
    <tradeName>PLASTI-MED</tradeName>
    <deviceName>HYDROPHILIC NITINOL GUIDE WIRE 0.028" 150 cm STRAIGHT TIP</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>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>536003</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T14:28:13.984Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699412332025</udiDi>
    <basicUdiDi>B-08699412332025</basicUdiDi>
    <tradeName>PLASTI-MED</tradeName>
    <deviceName>HYDROPHILIC NITINOL GUIDE WIRE 0.025" 150 cm STRAIGHT TIP</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>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>536002</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T14:28:11.584Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950203335116</udiDi>
    <basicUdiDi>69502033UGBYA</basicUdiDi>
    <tradeName>06950203335116</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Innovex Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015981</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVX-UG-3515BSO</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-09T08:28:16.287Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950203335178</udiDi>
    <basicUdiDi>69502033UGTZE</basicUdiDi>
    <tradeName>06950203335178</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Innovex Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015981</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U0602</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVX-UG-3515TSO</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-09T08:28:16.259Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950203335857</udiDi>
    <basicUdiDi>69502033UGUZG</basicUdiDi>
    <tradeName>06950203335857</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Innovex Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015981</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVX-UG-3515USR</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-09T08:28:16.196Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950203336199</udiDi>
    <basicUdiDi>69502033UGUZG</basicUdiDi>
    <tradeName>06950203336199</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Innovex Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015981</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVX-UG-3815USO</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-09T08:28:16.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950203336410</udiDi>
    <basicUdiDi>69502033UGNZ2</basicUdiDi>
    <tradeName>06950203336410</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Innovex Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015981</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVX-UG-3815NSO</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-09T08:28:16.133Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950203336458</udiDi>
    <basicUdiDi>69502033UGLYW</basicUdiDi>
    <tradeName>06950203336458</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Innovex Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015981</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U0602</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVX-UG-3815LSO</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-09T08:28:16.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972263489486</udiDi>
    <basicUdiDi>B-06972263489486</basicUdiDi>
    <tradeName>Disposable Nonvascular Guide Wires</tradeName>
    <deviceName>Disposable Nonvascular Guide Wires</deviceName>
    <manufacturerName>Jiangxi ZhuoRuiHua Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027760</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B-06972263489486</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:48:03.876Z</lastUpdated>
  </row>
</eudamedExport>