<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800023717778</udiDi>
    <basicUdiDi>B-08800023717778</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>SJ-AC5-IMA-100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:34:47.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023717754</udiDi>
    <basicUdiDi>B-08800023717754</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>SJ-AC4-IMA-100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:34:41.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023717730</udiDi>
    <basicUdiDi>B-08800023717730</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>SJ-AC5-IMA-080</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:34:40.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023717716</udiDi>
    <basicUdiDi>B-08800023717716</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>SJ-AC4-IMA-080</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:34:39.351Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023717693</udiDi>
    <basicUdiDi>B-08800023717693</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>SJ-AC5-IMA-065</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:34:38.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023717679</udiDi>
    <basicUdiDi>B-08800023717679</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>SJ-AC4-IMA-065</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:34:32.134Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023717655</udiDi>
    <basicUdiDi>B-08800023717655</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>SJ-AC6-MPB2-100-2s</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:34:30.960Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023717631</udiDi>
    <basicUdiDi>B-08800023717631</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>SJ-AC5-MPB2-100-2s</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:34:29.729Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023717617</udiDi>
    <basicUdiDi>B-08800023717617</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>SJ-AC4-MPB2-100-2s</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:34:28.533Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023717594</udiDi>
    <basicUdiDi>B-08800023717594</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>SJ-AC6-MPB1-100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:34:22.524Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023717570</udiDi>
    <basicUdiDi>B-08800023717570</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>SJ-AC5-MPB1-100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:34:21.342Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023717556</udiDi>
    <basicUdiDi>B-08800023717556</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>SJ-AC4-MPB1-100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:34:20.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023717532</udiDi>
    <basicUdiDi>B-08800023717532</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>SJ-AC6-MPA2-100-2s</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:34:18.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023717518</udiDi>
    <basicUdiDi>B-08800023717518</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>SJ-AC5-MPA2-100-2s</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:34:12.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023717495</udiDi>
    <basicUdiDi>B-08800023717495</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>SJ-AC4-MPA2-100-2s</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:34:11.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023717471</udiDi>
    <basicUdiDi>B-08800023717471</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>SJ-AC6-MPA1-100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:34:10.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023717457</udiDi>
    <basicUdiDi>B-08800023717457</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>SJ-AC5-MPA1-100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:34:09.334Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023717433</udiDi>
    <basicUdiDi>B-08800023717433</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>SJ-AC4-MPA1-100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:34:03.310Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023717419</udiDi>
    <basicUdiDi>B-08800023717419</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>SJ-AC6-AL3-100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:34:02.111Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023717396</udiDi>
    <basicUdiDi>B-08800023717396</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>SJ-AC5-AL3-100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:34:00.908Z</lastUpdated>
  </row>
</eudamedExport>