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    <deviceName>MedK Hydrophilic Guidewires</deviceName>
    <manufacturerName>medK GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006273</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>98261AGNC150HPC025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T12:00:02.182Z</lastUpdated>
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    <udiDi>08800023716092</udiDi>
    <basicUdiDi>B-08800023716092</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>
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    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-S35080</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:52:28.484Z</lastUpdated>
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    <udiDi>08800023716078</udiDi>
    <basicUdiDi>B-08800023716078</basicUdiDi>
    <tradeName>ANGUIS Guidewire</tradeName>
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    <manufacturerName>SUNGJIN-HITECH CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000036002</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-S35045</reference>
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    <lastUpdated>2026-07-09T17:52:26.883Z</lastUpdated>
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    <basicUdiDi>B-08800023716054</basicUdiDi>
    <tradeName>ANGUIS Guidewire</tradeName>
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    <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>
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    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-B35080</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:52:26.082Z</lastUpdated>
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    <udiDi>08800023716030</udiDi>
    <basicUdiDi>B-08800023716030</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-B35045</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:52:24.482Z</lastUpdated>
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    <udiDi>08800023716016</udiDi>
    <basicUdiDi>B-08800023716016</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-3J35080</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:52:22.082Z</lastUpdated>
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    <udiDi>08800023715996</udiDi>
    <basicUdiDi>B-08800023715996</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>
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    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-3J35045</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:52:20.480Z</lastUpdated>
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    <udiDi>08800023715972</udiDi>
    <basicUdiDi>B-08800023715972</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-15J35045</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:52:19.686Z</lastUpdated>
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    <udiDi>08800023715958</udiDi>
    <basicUdiDi>B-08800023715958</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-S32260</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:52:18.078Z</lastUpdated>
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    <udiDi>08800023715934</udiDi>
    <basicUdiDi>B-08800023715934</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-S32200</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:52:15.674Z</lastUpdated>
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    <udiDi>08800023715910</udiDi>
    <basicUdiDi>B-08800023715910</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-S32110</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:52:14.073Z</lastUpdated>
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    <udiDi>08800023715897</udiDi>
    <basicUdiDi>B-08800023715897</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-S32080</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:52:13.276Z</lastUpdated>
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    <udiDi>08800023715873</udiDi>
    <basicUdiDi>B-08800023715873</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-S32045</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:52:11.674Z</lastUpdated>
  </row>
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    <udiDi>08800023715859</udiDi>
    <basicUdiDi>B-08800023715859</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-B32260</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:52:09.266Z</lastUpdated>
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    <udiDi>08800023715835</udiDi>
    <basicUdiDi>B-08800023715835</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-B32200</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:52:07.672Z</lastUpdated>
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    <udiDi>08800023715811</udiDi>
    <basicUdiDi>B-08800023715811</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>
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    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-B32150</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:52:06.899Z</lastUpdated>
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    <udiDi>08800023715750</udiDi>
    <basicUdiDi>B-08800023715750</basicUdiDi>
    <tradeName>ANGUIS Guidewire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUNGJIN-HITECH CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000036002</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
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    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-B32045</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:52:05.264Z</lastUpdated>
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    <tradeName>ANGUIS Guidewire</tradeName>
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    <manufacturerName>SUNGJIN-HITECH CO., LTD</manufacturerName>
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    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
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    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-B32110</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:52:02.865Z</lastUpdated>
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    <tradeName>ANGUIS Guidewire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUNGJIN-HITECH CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000036002</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
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    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-B32080</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:52:01.283Z</lastUpdated>
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    <tradeName>ANGUIS Guidewire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUNGJIN-HITECH CO., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000036002</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
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    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW-3J32260</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:52:00.471Z</lastUpdated>
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