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<eudamedExport entity="devices">
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    <basicUdiDi>B-08800023720570</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-P180-060-5s</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:40:41.975Z</lastUpdated>
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    <udiDi>08800023720556</udiDi>
    <basicUdiDi>B-08800023720556</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-C3-100-2s</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:40:35.961Z</lastUpdated>
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    <udiDi>08800023720532</udiDi>
    <basicUdiDi>B-08800023720532</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-C3-100-2s</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:40:34.762Z</lastUpdated>
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  <row>
    <udiDi>08800023720518</udiDi>
    <basicUdiDi>B-08800023720518</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-C3-100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:40:33.567Z</lastUpdated>
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  <row>
    <udiDi>08800023720495</udiDi>
    <basicUdiDi>B-08800023720495</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-C3-100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:40:32.374Z</lastUpdated>
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  <row>
    <udiDi>08800023720471</udiDi>
    <basicUdiDi>B-08800023720471</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-C3-080-2s</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:40:26.355Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023720457</udiDi>
    <basicUdiDi>B-08800023720457</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-C3-080</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:40:25.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023720433</udiDi>
    <basicUdiDi>B-08800023720433</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-C3-065-2s</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:40:22.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023720419</udiDi>
    <basicUdiDi>B-08800023720419</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-C3-065-2s</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:40:21.555Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023720396</udiDi>
    <basicUdiDi>B-08800023720396</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-C3-065</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:40:15.575Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023720372</udiDi>
    <basicUdiDi>B-08800023720372</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-C3-065</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:40:14.360Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023720358</udiDi>
    <basicUdiDi>B-08800023720358</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-C2-100-2s</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:40:13.149Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023720334</udiDi>
    <basicUdiDi>B-08800023720334</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-C2-075</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:40:11.950Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023720310</udiDi>
    <basicUdiDi>B-08800023720310</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-C2-070</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:40:06.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800023720297</udiDi>
    <basicUdiDi>B-08800023720297</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-C2-070</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:40:03.543Z</lastUpdated>
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    <udiDi>08800023720273</udiDi>
    <basicUdiDi>B-08800023720273</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-C2-065</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:40:02.345Z</lastUpdated>
  </row>
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    <udiDi>08800023720259</udiDi>
    <basicUdiDi>B-08800023720259</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-C1-100-2s</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:40:01.139Z</lastUpdated>
  </row>
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    <udiDi>08800023720235</udiDi>
    <basicUdiDi>B-08800023720235</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-C1-100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:39:55.138Z</lastUpdated>
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    <udiDi>08800023720211</udiDi>
    <basicUdiDi>B-08800023720211</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-C1-100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:39:53.927Z</lastUpdated>
  </row>
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    <udiDi>08800023720198</udiDi>
    <basicUdiDi>B-08800023720198</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-C1-080-2s</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:39:52.741Z</lastUpdated>
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</eudamedExport>