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<eudamedExport entity="devices">
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    <basicUdiDi>880924406AREXKQ</basicUdiDi>
    <tradeName>BELLIGER ACE</tradeName>
    <deviceName>BELLIGER ACE (AREX)</deviceName>
    <manufacturerName>GENORAY CO., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000021014</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039009</emdnCode>
    <emdnDescription>FLUOROSCOPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A03</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:47:29.465Z</lastUpdated>
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    <udiDi>08809244060120</udiDi>
    <basicUdiDi>880924406ZEN2090QJ</basicUdiDi>
    <tradeName>ZEN-2090 Turbo</tradeName>
    <deviceName>ZEN-2090 Turbo (XENO-360)</deviceName>
    <manufacturerName>GENORAY CO., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000021014</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039009</emdnCode>
    <emdnDescription>FLUOROSCOPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>111</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:47:28.654Z</lastUpdated>
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  <row>
    <udiDi>08809244060106</udiDi>
    <basicUdiDi>880924406OSCARKZ</basicUdiDi>
    <tradeName>OSCAR Prime</tradeName>
    <deviceName>OSCAR (OSCAR Prime(Unique Start FD), OSCAR Classic (Unique Class))</deviceName>
    <manufacturerName>GENORAY CO., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000021014</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039009</emdnCode>
    <emdnDescription>FLUOROSCOPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:47:27.053Z</lastUpdated>
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    <udiDi>08809244060069</udiDi>
    <basicUdiDi>880924406OSCAR15UD</basicUdiDi>
    <tradeName>OSCAR 15i</tradeName>
    <deviceName>OSCAR 15FD (Unique FD, OPESCOPE ACTENO FD15, SC15), OSCAR 15i, OSCAR 15iL</deviceName>
    <manufacturerName>GENORAY CO., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000021014</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039009</emdnCode>
    <emdnDescription>FLUOROSCOPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:47:24.647Z</lastUpdated>
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  <row>
    <udiDi>08054890480109</udiDi>
    <basicUdiDi>805489048SRFRD</basicUdiDi>
    <tradeName>DISCOVERY RF180</tradeName>
    <deviceName>RF rooms</deviceName>
    <manufacturerName>General Medical Merate S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000023169</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039009</emdnCode>
    <emdnDescription>FLUOROSCOPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DISCOVERY RF180</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:15:11.433Z</lastUpdated>
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  <row>
    <udiDi>08053470960062</udiDi>
    <basicUdiDi>805347096CARM218V</basicUdiDi>
    <tradeName>C015</tradeName>
    <deviceName>FLUOROSCOPIC DEVICE UNITS</deviceName>
    <manufacturerName>Micronica Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000018986</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039009</emdnCode>
    <emdnDescription>FLUOROSCOPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1 130 0104; 1 130 0105; 1 130 0106; 1 135 0011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:43:39.388Z</lastUpdated>
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  <row>
    <udiDi>06974265032110</udiDi>
    <basicUdiDi>697426503100JF</basicUdiDi>
    <tradeName>Medical Diagnostic X-Ray Equipment</tradeName>
    <deviceName>Medical Diagnostic X-Ray Equipment</deviceName>
    <manufacturerName>Zhuhai Perlead Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025749</manufacturerSrn>
    <authorisedRepresentativeName>BioDomi GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016611</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039009</emdnCode>
    <emdnDescription>FLUOROSCOPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PLD9600B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:48:47.937Z</lastUpdated>
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  <row>
    <udiDi>06971576833610</udiDi>
    <basicUdiDi>697157683361NP</basicUdiDi>
    <tradeName>06971576833610</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanghai United Imaging Healthcare Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008501</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039009</emdnCode>
    <emdnDescription>FLUOROSCOPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88001399</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:06:17.756Z</lastUpdated>
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  <row>
    <udiDi>06971576833603</udiDi>
    <basicUdiDi>697157683360NM</basicUdiDi>
    <tradeName>06971576833603</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanghai United Imaging Healthcare Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008501</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039009</emdnCode>
    <emdnDescription>FLUOROSCOPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88001398</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:06:16.947Z</lastUpdated>
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  <row>
    <udiDi>06938964313208</udiDi>
    <basicUdiDi>693896431300NC</basicUdiDi>
    <tradeName>06938964313208</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Wandong Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014174</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11039009</emdnCode>
    <emdnDescription>FLUOROSCOPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GMDN Code: 37679</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T07:55:15.821Z</lastUpdated>
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  <row>
    <udiDi>06938964313222</udiDi>
    <basicUdiDi>693896431300NC</basicUdiDi>
    <tradeName>06938964313222</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Wandong Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014174</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11039009</emdnCode>
    <emdnDescription>FLUOROSCOPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GMDN Code: 37679</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T07:55:15.794Z</lastUpdated>
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    <udiDi>06938964313260</udiDi>
    <basicUdiDi>693896431300NC</basicUdiDi>
    <tradeName>06938964313260</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Wandong Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014174</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11039009</emdnCode>
    <emdnDescription>FLUOROSCOPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GMDN Code: 37679</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T07:55:15.770Z</lastUpdated>
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  <row>
    <udiDi>06945429060430</udiDi>
    <basicUdiDi>69454290ME001LH</basicUdiDi>
    <tradeName>Medical Examination Light</tradeName>
    <deviceName>Medical Examination Light</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039009</emdnCode>
    <emdnDescription>FLUOROSCOPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL10A</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:29:23.201Z</lastUpdated>
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    <udiDi>06945429060423</udiDi>
    <basicUdiDi>69454290ME001LH</basicUdiDi>
    <tradeName>Medical Examination Light</tradeName>
    <deviceName>Medical Examination Light</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039009</emdnCode>
    <emdnDescription>FLUOROSCOPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL10</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:29:20.818Z</lastUpdated>
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    <udiDi>08809365283040</udiDi>
    <basicUdiDi>880936528MCASB</basicUdiDi>
    <tradeName>GARION+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SG Healthcare Co.,Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000011322</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039009</emdnCode>
    <emdnDescription>FLUOROSCOPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GARION+</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:30:38.834Z</lastUpdated>
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    <udiDi>08053470960086</udiDi>
    <basicUdiDi>805347096CARM218V</basicUdiDi>
    <tradeName>C015</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Micronica Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000018986</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039009</emdnCode>
    <emdnDescription>FLUOROSCOPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1 130 0004; 1 130 0005; 1 130 0006; 1 135 0001; 1 135 0002; 1 135 0101; 1 135 0102</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:46:51.729Z</lastUpdated>
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    <udiDi>08053470960079</udiDi>
    <basicUdiDi>805347096CARM218V</basicUdiDi>
    <tradeName>C015</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Micronica Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000018986</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039009</emdnCode>
    <emdnDescription>FLUOROSCOPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1 130 0001; 1 130 0002; 1 130 0003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:46:51.356Z</lastUpdated>
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    <udiDi>04056869993980</udiDi>
    <basicUdiDi>0405686901994WS</basicUdiDi>
    <tradeName>LUMINOS Q.namix T</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006122</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039009</emdnCode>
    <emdnDescription>FLUOROSCOPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11574003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T08:15:10.201Z</lastUpdated>
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    <udiDi>08809244060113</udiDi>
    <basicUdiDi>880924406OSCARKZ</basicUdiDi>
    <tradeName>OSCAR Classic</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GENORAY CO., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000021014</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039009</emdnCode>
    <emdnDescription>FLUOROSCOPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:53:35.434Z</lastUpdated>
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    <udiDi>08809244060168</udiDi>
    <basicUdiDi>880924406OSCAR15UD</basicUdiDi>
    <tradeName>Unique FD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GENORAY CO., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000021014</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039009</emdnCode>
    <emdnDescription>FLUOROSCOPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:53:35.386Z</lastUpdated>
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