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<eudamedExport entity="devices">
  <row>
    <udiDi>08800026543152</udiDi>
    <basicUdiDi>B-08800026543152</basicUdiDi>
    <tradeName>DIVES MED ULTRA LIDOCAINE (FINE LINES)</tradeName>
    <deviceName>DIVES MED ULTRA LIDOCAINE (FINE LINES)</deviceName>
    <manufacturerName>GENOSS Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000029064</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P900402</emdnCode>
    <emdnDescription>RESORBABLE FILLING AND RECONSTRUCTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPF10S</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:45:25.375Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026543145</udiDi>
    <basicUdiDi>B-08800026543145</basicUdiDi>
    <tradeName>INFINI PREMIUM FILLER (Soft Lip+)</tradeName>
    <deviceName>INFINI PREMIUM FILLER (Soft Lip+)</deviceName>
    <manufacturerName>GENOSS Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000029064</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P900402</emdnCode>
    <emdnDescription>RESORBABLE FILLING AND RECONSTRUCTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPF10S</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:45:24.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800024300672</udiDi>
    <basicUdiDi>B-08800024300672</basicUdiDi>
    <tradeName>Hello, Eyes</tradeName>
    <deviceName>Biodegradable lacrimal punctum plug for relieve the dry eye syndrome</deviceName>
    <manufacturerName>BIO Optics Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000042788</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q020703</emdnCode>
    <emdnDescription>LACRIMAL DUCT PLUGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Bio Plug 0.3</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:45:22.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800024300016</udiDi>
    <basicUdiDi>B-08800024300016</basicUdiDi>
    <tradeName>Hello, Eyes</tradeName>
    <deviceName>Sterile Polydioxanone Lacrimal Punctum Plug</deviceName>
    <manufacturerName>BIO Optics Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000042788</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q020703</emdnCode>
    <emdnDescription>LACRIMAL DUCT PLUGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Bio Plug 0.5</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:45:21.775Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800024300009</udiDi>
    <basicUdiDi>B-08800024300009</basicUdiDi>
    <tradeName>Hello, Eyes</tradeName>
    <deviceName>Biodegradable lacrimal punctum plug for relieve the dry eye syndrome</deviceName>
    <manufacturerName>BIO Optics Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000042788</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q020703</emdnCode>
    <emdnDescription>LACRIMAL DUCT PLUGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Bio Plug 0.4</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:45:15.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023722857</udiDi>
    <basicUdiDi>B-08800023722857</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>RA-AC5-ST-125</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:45:14.555Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023722833</udiDi>
    <basicUdiDi>B-08800023722833</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>RA-AC4-ST-125</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:45:13.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023722819</udiDi>
    <basicUdiDi>B-08800023722819</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>RA-AC5-ST-100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:45:12.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023722796</udiDi>
    <basicUdiDi>B-08800023722796</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>RA-AC4-ST-100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:45:06.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023722772</udiDi>
    <basicUdiDi>B-08800023722772</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>RA-AC5-ST-080</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:45:04.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023722758</udiDi>
    <basicUdiDi>B-08800023722758</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>RA-AC4-ST-080</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:45:03.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023722734</udiDi>
    <basicUdiDi>B-08800023722734</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>RA-AC4-ST-065</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:45:02.547Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023722710</udiDi>
    <basicUdiDi>B-08800023722710</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>RA-AC5-MIK-125</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:44:56.546Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023722697</udiDi>
    <basicUdiDi>B-08800023722697</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>RA-AC4-MIK-125</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:44:55.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023722673</udiDi>
    <basicUdiDi>B-08800023722673</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>RA-AC4-MIK-100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:44:54.152Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023722659</udiDi>
    <basicUdiDi>B-08800023722659</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>RA-AC4-MIK-080</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:44:52.962Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023722635</udiDi>
    <basicUdiDi>B-08800023722635</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>RA-AC5-MIK-065</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:44:46.952Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023722611</udiDi>
    <basicUdiDi>B-08800023722611</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>RA-AC4-MIK-065</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:44:45.737Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023722598</udiDi>
    <basicUdiDi>B-08800023722598</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>RA-AC4-JB2-125</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:44:44.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023722574</udiDi>
    <basicUdiDi>B-08800023722574</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>RA-AC4-JB2-100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:44:43.335Z</lastUpdated>
  </row>
</eudamedExport>