<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800023702156</udiDi>
    <basicUdiDi>B-08800023702156</basicUdiDi>
    <tradeName>GRAFIA Angiographic catheter</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 III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020101</emdnCode>
    <emdnDescription>PANORAMIC AND SELECTIVE PERIPHERAL DIAGNOSTIC ANGIOGRAPHY CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL-AC5-P180-100-5s</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:24:50.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023702149</udiDi>
    <basicUdiDi>B-08800023702149</basicUdiDi>
    <tradeName>GRAFIA Angiographic catheter</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 III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020101</emdnCode>
    <emdnDescription>PANORAMIC AND SELECTIVE PERIPHERAL DIAGNOSTIC ANGIOGRAPHY CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL-AC5-P180-080-10s</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:24:48.971Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023702132</udiDi>
    <basicUdiDi>B-08800023702132</basicUdiDi>
    <tradeName>GRAFIA Angiographic catheter</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 III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020101</emdnCode>
    <emdnDescription>PANORAMIC AND SELECTIVE PERIPHERAL DIAGNOSTIC ANGIOGRAPHY CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL-AC5-P180-080-8s</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:24:47.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023702125</udiDi>
    <basicUdiDi>B-08800023702125</basicUdiDi>
    <tradeName>GRAFIA Angiographic catheter</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 III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020101</emdnCode>
    <emdnDescription>PANORAMIC AND SELECTIVE PERIPHERAL DIAGNOSTIC ANGIOGRAPHY CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL-AC5-P180-080-5s</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:24:41.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023702118</udiDi>
    <basicUdiDi>B-08800023702118</basicUdiDi>
    <tradeName>GRAFIA Angiographic catheter</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 III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020101</emdnCode>
    <emdnDescription>PANORAMIC AND SELECTIVE PERIPHERAL DIAGNOSTIC ANGIOGRAPHY CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL-AC5-P180-065-10s</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:24:40.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023702101</udiDi>
    <basicUdiDi>B-08800023702101</basicUdiDi>
    <tradeName>GRAFIA Angiographic catheter</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 III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020101</emdnCode>
    <emdnDescription>PANORAMIC AND SELECTIVE PERIPHERAL DIAGNOSTIC ANGIOGRAPHY CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL-AC5-P180-065-8s</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:24:39.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023702095</udiDi>
    <basicUdiDi>B-08800023702095</basicUdiDi>
    <tradeName>GRAFIA Angiographic catheter</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 III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020101</emdnCode>
    <emdnDescription>PANORAMIC AND SELECTIVE PERIPHERAL DIAGNOSTIC ANGIOGRAPHY CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL-AC5-P180-065-5s</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:24:38.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023701982</udiDi>
    <basicUdiDi>B-08800023701982</basicUdiDi>
    <tradeName>GRAFIA Angiographic catheter</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 III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020101</emdnCode>
    <emdnDescription>PANORAMIC AND SELECTIVE PERIPHERAL DIAGNOSTIC ANGIOGRAPHY CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL-AC5-P135-100-10s</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:24:32.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023701975</udiDi>
    <basicUdiDi>B-08800023701975</basicUdiDi>
    <tradeName>GRAFIA Angiographic catheter</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 III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020101</emdnCode>
    <emdnDescription>PANORAMIC AND SELECTIVE PERIPHERAL DIAGNOSTIC ANGIOGRAPHY CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL-AC5-KMP-100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:24:30.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023701968</udiDi>
    <basicUdiDi>B-08800023701968</basicUdiDi>
    <tradeName>GRAFIA Angiographic catheter</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 III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020101</emdnCode>
    <emdnDescription>PANORAMIC AND SELECTIVE PERIPHERAL DIAGNOSTIC ANGIOGRAPHY CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL-AC5-KMP-080</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:24:29.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023701951</udiDi>
    <basicUdiDi>B-08800023701951</basicUdiDi>
    <tradeName>GRAFIA Angiographic catheter</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 III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020101</emdnCode>
    <emdnDescription>PANORAMIC AND SELECTIVE PERIPHERAL DIAGNOSTIC ANGIOGRAPHY CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL-AC5-KMP-065</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:24:28.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023701944</udiDi>
    <basicUdiDi>B-08800023701944</basicUdiDi>
    <tradeName>GRAFIA Angiographic catheter</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 III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020101</emdnCode>
    <emdnDescription>PANORAMIC AND SELECTIVE PERIPHERAL DIAGNOSTIC ANGIOGRAPHY CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL-AC5-KMP-040</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:24:22.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023701937</udiDi>
    <basicUdiDi>B-08800023701937</basicUdiDi>
    <tradeName>GRAFIA Angiographic catheter</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 III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020101</emdnCode>
    <emdnDescription>PANORAMIC AND SELECTIVE PERIPHERAL DIAGNOSTIC ANGIOGRAPHY CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL-AC5-YA-070</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:24:21.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023701920</udiDi>
    <basicUdiDi>B-08800023701920</basicUdiDi>
    <tradeName>GRAFIA Angiographic catheter</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 III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020101</emdnCode>
    <emdnDescription>PANORAMIC AND SELECTIVE PERIPHERAL DIAGNOSTIC ANGIOGRAPHY CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL-AC5-RS-080</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:24:20.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023701913</udiDi>
    <basicUdiDi>B-08800023701913</basicUdiDi>
    <tradeName>GRAFIA Angiographic catheter</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 III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020101</emdnCode>
    <emdnDescription>PANORAMIC AND SELECTIVE PERIPHERAL DIAGNOSTIC ANGIOGRAPHY CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL-AC5-RH-080</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:24:18.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023701906</udiDi>
    <basicUdiDi>B-08800023701906</basicUdiDi>
    <tradeName>GRAFIA Angiographic catheter</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 III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020101</emdnCode>
    <emdnDescription>PANORAMIC AND SELECTIVE PERIPHERAL DIAGNOSTIC ANGIOGRAPHY CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL-AC5-C3-100-2s</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:24:12.928Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023701890</udiDi>
    <basicUdiDi>B-08800023701890</basicUdiDi>
    <tradeName>GRAFIA Angiographic catheter</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 III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020101</emdnCode>
    <emdnDescription>PANORAMIC AND SELECTIVE PERIPHERAL DIAGNOSTIC ANGIOGRAPHY CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL-AC5-C3-100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:24:11.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023701883</udiDi>
    <basicUdiDi>B-08800023701883</basicUdiDi>
    <tradeName>GRAFIA Angiographic catheter</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 III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020101</emdnCode>
    <emdnDescription>PANORAMIC AND SELECTIVE PERIPHERAL DIAGNOSTIC ANGIOGRAPHY CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL-AC5-C3-080-2s</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:24:10.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023701876</udiDi>
    <basicUdiDi>B-08800023701876</basicUdiDi>
    <tradeName>GRAFIA Angiographic catheter</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 III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020101</emdnCode>
    <emdnDescription>PANORAMIC AND SELECTIVE PERIPHERAL DIAGNOSTIC ANGIOGRAPHY CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL-AC5-C3-080</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:24:09.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023701869</udiDi>
    <basicUdiDi>B-08800023701869</basicUdiDi>
    <tradeName>GRAFIA Angiographic catheter</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 III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020101</emdnCode>
    <emdnDescription>PANORAMIC AND SELECTIVE PERIPHERAL DIAGNOSTIC ANGIOGRAPHY CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EL-AC5-C3-065-2s</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:24:03.329Z</lastUpdated>
  </row>
</eudamedExport>