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    <tradeName>Coil Pusher</tradeName>
    <deviceName>Microcoils-18 Coil Pusher</deviceName>
    <manufacturerName>William Cook Europe ApS</manufacturerName>
    <manufacturerSrn>DK-MF-000000911</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020399</emdnCode>
    <emdnDescription>EMBOLISATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP-18-180</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:26:10.672Z</lastUpdated>
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    <udiDi>07290016441123</udiDi>
    <basicUdiDi>7290016441003W7</basicUdiDi>
    <tradeName>Brook L</tradeName>
    <deviceName>Brook</deviceName>
    <manufacturerName>Perflow Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000009315</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP III GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011191</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010402020380</emdnCode>
    <emdnDescription>EMBOLISATION DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG0017</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:19:15.884Z</lastUpdated>
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    <udiDi>00810563021363</udiDi>
    <basicUdiDi>089947500200141PN</basicUdiDi>
    <tradeName>40um Tandem 2mL - INTL</tradeName>
    <deviceName>TANDEM</deviceName>
    <manufacturerName>Varian Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007453</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthineers Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000803</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010402020303</emdnCode>
    <emdnDescription>EMBOLISATION PARTICLES AND MICROSPHERES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10420-TS0</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T07:56:57.532Z</lastUpdated>
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    <udiDi>00810563021165</udiDi>
    <basicUdiDi>089947500200139Q3</basicUdiDi>
    <tradeName>40um Embozene 1mL Colored - INTL</tradeName>
    <deviceName>Embozene®Color-Advanced Microspheres</deviceName>
    <manufacturerName>Varian Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007453</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthineers Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000803</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010402020303</emdnCode>
    <emdnDescription>EMBOLISATION PARTICLES AND MICROSPHERES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10410-S1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T07:56:56.334Z</lastUpdated>
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    <udiDi>08800038405202</udiDi>
    <basicUdiDi>B-08800038405202</basicUdiDi>
    <tradeName>Nexsphere™</tradeName>
    <deviceName>Embolic gelatin microspheres</deviceName>
    <manufacturerName>NEXTBIOMEDICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000004808</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020303</emdnCode>
    <emdnDescription>EMBOLISATION PARTICLES AND MICROSPHERES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Nexsphere-H</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:55:40.165Z</lastUpdated>
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    <udiDi>08800038405196</udiDi>
    <basicUdiDi>B-08800038405196</basicUdiDi>
    <tradeName>Nexsphere-F™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NEXTBIOMEDICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000004808</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020303</emdnCode>
    <emdnDescription>EMBOLISATION PARTICLES AND MICROSPHERES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Nexsphere-F</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:55:38.972Z</lastUpdated>
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    <udiDi>08800038404533</udiDi>
    <basicUdiDi>B-08800038404533</basicUdiDi>
    <tradeName>Nexsphere™</tradeName>
    <deviceName>Embolic gelatin microspheres</deviceName>
    <manufacturerName>NEXTBIOMEDICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000004808</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020303</emdnCode>
    <emdnDescription>EMBOLISATION PARTICLES AND MICROSPHERES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UIGB700</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:55:32.962Z</lastUpdated>
  </row>
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    <udiDi>08800038404526</udiDi>
    <basicUdiDi>B-08800038404526</basicUdiDi>
    <tradeName>Nexsphere™</tradeName>
    <deviceName>Embolic gelatin microspheres</deviceName>
    <manufacturerName>NEXTBIOMEDICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000004808</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020303</emdnCode>
    <emdnDescription>EMBOLISATION PARTICLES AND MICROSPHERES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UIGB500</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:55:31.772Z</lastUpdated>
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  <row>
    <udiDi>08800038404519</udiDi>
    <basicUdiDi>B-08800038404519</basicUdiDi>
    <tradeName>Nexsphere™</tradeName>
    <deviceName>Embolic gelatin microspheres</deviceName>
    <manufacturerName>NEXTBIOMEDICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000004808</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020303</emdnCode>
    <emdnDescription>EMBOLISATION PARTICLES AND MICROSPHERES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UIGB300</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:55:30.583Z</lastUpdated>
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    <udiDi>08800038404502</udiDi>
    <basicUdiDi>B-08800038404502</basicUdiDi>
    <tradeName>Nexsphere™</tradeName>
    <deviceName>Embolic gelatin microspheres</deviceName>
    <manufacturerName>NEXTBIOMEDICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000004808</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020303</emdnCode>
    <emdnDescription>EMBOLISATION PARTICLES AND MICROSPHERES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UIGB100</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:55:29.397Z</lastUpdated>
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    <udiDi>06970908211102</udiDi>
    <basicUdiDi>B-06970908211102</basicUdiDi>
    <tradeName>06970908211102</tradeName>
    <deviceName>Wallaby Avenir™ Coil System</deviceName>
    <manufacturerName>Wallaby Medical</manufacturerName>
    <manufacturerSrn>US-MF-000010241</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020301</emdnCode>
    <emdnDescription>EMBOLISATION COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10CFN05010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:28:42.691Z</lastUpdated>
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    <udiDi>06970908211096</udiDi>
    <basicUdiDi>B-06970908211096</basicUdiDi>
    <tradeName>06970908211096</tradeName>
    <deviceName>Wallaby Avenir™ Coil System</deviceName>
    <manufacturerName>Wallaby Medical</manufacturerName>
    <manufacturerSrn>US-MF-000010241</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020301</emdnCode>
    <emdnDescription>EMBOLISATION COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10CFN05008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:28:41.494Z</lastUpdated>
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    <udiDi>06970908211089</udiDi>
    <basicUdiDi>B-06970908211089</basicUdiDi>
    <tradeName>06970908211089</tradeName>
    <deviceName>Wallaby Avenir™ Coil System</deviceName>
    <manufacturerName>Wallaby Medical</manufacturerName>
    <manufacturerSrn>US-MF-000010241</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020301</emdnCode>
    <emdnDescription>EMBOLISATION COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10CFN04010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:28:37.891Z</lastUpdated>
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    <udiDi>06970908211072</udiDi>
    <basicUdiDi>B-06970908211072</basicUdiDi>
    <tradeName>06970908211072</tradeName>
    <deviceName>Wallaby Avenir™ Coil System</deviceName>
    <manufacturerName>Wallaby Medical</manufacturerName>
    <manufacturerSrn>US-MF-000010241</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020301</emdnCode>
    <emdnDescription>EMBOLISATION COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10CFN04008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:28:33.101Z</lastUpdated>
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    <udiDi>06970908211065</udiDi>
    <basicUdiDi>B-06970908211065</basicUdiDi>
    <tradeName>06970908211065</tradeName>
    <deviceName>Wallaby Avenir™ Coil System</deviceName>
    <manufacturerName>Wallaby Medical</manufacturerName>
    <manufacturerSrn>US-MF-000010241</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020301</emdnCode>
    <emdnDescription>EMBOLISATION COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10CFN04006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:28:31.884Z</lastUpdated>
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    <udiDi>06970908211058</udiDi>
    <basicUdiDi>B-06970908211058</basicUdiDi>
    <tradeName>06970908211058</tradeName>
    <deviceName>Wallaby Avenir™ Coil System</deviceName>
    <manufacturerName>Wallaby Medical</manufacturerName>
    <manufacturerSrn>US-MF-000010241</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020301</emdnCode>
    <emdnDescription>EMBOLISATION COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10CFN03010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:28:30.685Z</lastUpdated>
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    <udiDi>06970908211034</udiDi>
    <basicUdiDi>B-06970908211034</basicUdiDi>
    <tradeName>06970908211034</tradeName>
    <deviceName>Wallaby Avenir™ Coil System</deviceName>
    <manufacturerName>Wallaby Medical</manufacturerName>
    <manufacturerSrn>US-MF-000010241</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020301</emdnCode>
    <emdnDescription>EMBOLISATION COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10CFN03006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:28:22.278Z</lastUpdated>
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    <udiDi>06970908211027</udiDi>
    <basicUdiDi>B-06970908211027</basicUdiDi>
    <tradeName>06970908211027</tradeName>
    <deviceName>Wallaby Avenir™ Coil System</deviceName>
    <manufacturerName>Wallaby Medical</manufacturerName>
    <manufacturerSrn>US-MF-000010241</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020301</emdnCode>
    <emdnDescription>EMBOLISATION COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10CFN03004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:28:21.114Z</lastUpdated>
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    <udiDi>06970908211010</udiDi>
    <basicUdiDi>B-06970908211010</basicUdiDi>
    <tradeName>06970908211010</tradeName>
    <deviceName>Wallaby Avenir™ Coil System</deviceName>
    <manufacturerName>Wallaby Medical</manufacturerName>
    <manufacturerSrn>US-MF-000010241</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020301</emdnCode>
    <emdnDescription>EMBOLISATION COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10CFN02504</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:28:19.890Z</lastUpdated>
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    <udiDi>06970908211003</udiDi>
    <basicUdiDi>B-06970908211003</basicUdiDi>
    <tradeName>06970908211003</tradeName>
    <deviceName>Wallaby Avenir™ Coil System</deviceName>
    <manufacturerName>Wallaby Medical</manufacturerName>
    <manufacturerSrn>US-MF-000010241</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020301</emdnCode>
    <emdnDescription>EMBOLISATION COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10CFN02503</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:28:18.676Z</lastUpdated>
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