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<eudamedExport entity="devices">
  <row>
    <udiDi>08800023712599</udiDi>
    <basicUdiDi>B-08800023712599</basicUdiDi>
    <tradeName>ANGUIS Guidewire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUNGJIN-HITECH CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000036002</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-A14165</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:45:34.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023712650</udiDi>
    <basicUdiDi>B-08800023712650</basicUdiDi>
    <tradeName>ANGUIS Guidewire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUNGJIN-HITECH CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000036002</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-AA14110</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:45:32.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023712636</udiDi>
    <basicUdiDi>B-08800023712636</basicUdiDi>
    <tradeName>ANGUIS Guidewire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUNGJIN-HITECH CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000036002</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-A14200</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:45:32.065Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023712575</udiDi>
    <basicUdiDi>B-08800023712575</basicUdiDi>
    <tradeName>ANGUIS Guidewire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUNGJIN-HITECH CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000036002</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-A14150</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:45:14.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023712551</udiDi>
    <basicUdiDi>B-08800023712551</basicUdiDi>
    <tradeName>ANGUIS Guidewire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUNGJIN-HITECH CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000036002</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-A14135</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:45:13.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023712537</udiDi>
    <basicUdiDi>B-08800023712537</basicUdiDi>
    <tradeName>ANGUIS Guidewire</tradeName>
    <deviceName>ANGUIS Guidewire</deviceName>
    <manufacturerName>SUNGJIN-HITECH CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000036002</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-A14110</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:45:11.804Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023712346</udiDi>
    <basicUdiDi>B-08800023712346</basicUdiDi>
    <tradeName>ANGUIS Guidewire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUNGJIN-HITECH CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000036002</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-A18165</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:45:10.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023710021</udiDi>
    <basicUdiDi>B-08800023710021</basicUdiDi>
    <tradeName>ANGUIS Guidewire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUNGJIN-HITECH CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000036002</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-A18150</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:45:06.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023704068</udiDi>
    <basicUdiDi>B-08800023704068</basicUdiDi>
    <tradeName>ANGUIS Guidewire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUNGJIN-HITECH CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000036002</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-A32180</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:45:06.190Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023704051</udiDi>
    <basicUdiDi>B-08800023704051</basicUdiDi>
    <tradeName>ANGUIS Guidewire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUNGJIN-HITECH CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000036002</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-A25260</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:45:05.389Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023703801</udiDi>
    <basicUdiDi>B-08800023703801</basicUdiDi>
    <tradeName>ANGUIS Guidewire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUNGJIN-HITECH CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000036002</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-3J32180</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:45:03.784Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023703795</udiDi>
    <basicUdiDi>B-08800023703795</basicUdiDi>
    <tradeName>ANGUIS Guidewire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUNGJIN-HITECH CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000036002</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-B32180</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:44:59.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023703788</udiDi>
    <basicUdiDi>B-08800023703788</basicUdiDi>
    <tradeName>ANGUIS Guidewire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUNGJIN-HITECH CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000036002</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-A25150</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:44:58.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023703771</udiDi>
    <basicUdiDi>B-08800023703771</basicUdiDi>
    <tradeName>ANGUIS Guidewire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUNGJIN-HITECH CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000036002</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-15J32180</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:44:58.183Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023703764</udiDi>
    <basicUdiDi>B-08800023703764</basicUdiDi>
    <tradeName>ANGUIS Guidewire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUNGJIN-HITECH CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000036002</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-15J25150</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:44:57.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023703757</udiDi>
    <basicUdiDi>B-08800023703757</basicUdiDi>
    <tradeName>ANGUIS Guidewire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUNGJIN-HITECH CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000036002</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-S32180</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:44:52.591Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023703740</udiDi>
    <basicUdiDi>B-08800023703740</basicUdiDi>
    <tradeName>ANGUIS Guidewire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUNGJIN-HITECH CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000036002</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-S25150</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:44:51.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023703733</udiDi>
    <basicUdiDi>B-08800023703733</basicUdiDi>
    <tradeName>ANGUIS Guidewire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUNGJIN-HITECH CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000036002</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-S16180</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:44:50.999Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023703641</udiDi>
    <basicUdiDi>B-08800023703641</basicUdiDi>
    <tradeName>ANGUIS Guidewire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUNGJIN-HITECH CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000036002</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-A32260</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:44:50.181Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023703214</udiDi>
    <basicUdiDi>B-08800023703214</basicUdiDi>
    <tradeName>ANGUIS Guidewire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUNGJIN-HITECH CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000036002</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-15J35080</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:44:46.187Z</lastUpdated>
  </row>
</eudamedExport>