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    <tradeName>AIDIA Nex</tradeName>
    <deviceName>Digital Mammography System</deviceName>
    <manufacturerName>DRTECH Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000012441</manufacturerSrn>
    <authorisedRepresentativeName>DRTECH Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011974</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RMF-2000B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:57:55.044Z</lastUpdated>
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    <udiDi>06950291110466</udiDi>
    <basicUdiDi>69502911DR3YB</basicUdiDi>
    <tradeName>06950291110466</tradeName>
    <deviceName>Mammography</deviceName>
    <manufacturerName>Sino Medical-Device Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007089</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Navigator DR Care</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:19:27.549Z</lastUpdated>
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    <udiDi>06950291110169</udiDi>
    <basicUdiDi>69502911MTQ</basicUdiDi>
    <tradeName>06950291110169</tradeName>
    <deviceName>Mammography</deviceName>
    <manufacturerName>Sino Medical-Device Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007089</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Navigator Star</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:19:19.938Z</lastUpdated>
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    <udiDi>06430035430147</udiDi>
    <basicUdiDi>6430035430055U</basicUdiDi>
    <tradeName>06430035430147</tradeName>
    <deviceName>Planmed Clarity+</deviceName>
    <manufacturerName>Planmed Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000006837</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30063790</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:54:38.681Z</lastUpdated>
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    <udiDi>06430035430116</udiDi>
    <basicUdiDi>6430035430025N</basicUdiDi>
    <tradeName>06430035430116</tradeName>
    <deviceName>Planmed Clarity</deviceName>
    <manufacturerName>Planmed Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000006837</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20009418</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:52:35.846Z</lastUpdated>
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    <udiDi>04630193910655</udiDi>
    <basicUdiDi>463019391HARMONIAW9</basicUdiDi>
    <tradeName>Harmonia C</tradeName>
    <deviceName>Mammography system</deviceName>
    <manufacturerName>MEDICAL TECHNOLOGIES Ltd</manufacturerName>
    <manufacturerSrn>RU-MF-000020612</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F0478E</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:20:05.626Z</lastUpdated>
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    <udiDi>00195278914026</udiDi>
    <basicUdiDi>8406821BUG00205GY</basicUdiDi>
    <tradeName>Pristina Via</tradeName>
    <deviceName>Senographe Pristina</deviceName>
    <manufacturerName>GE Medical Systems SCS</manufacturerName>
    <manufacturerSrn>FR-MF-000000687</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5969633</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:49:19.974Z</lastUpdated>
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  <row>
    <udiDi>08800018423301</udiDi>
    <basicUdiDi>88000184SMXXXXXXXXBV</basicUdiDi>
    <tradeName>AIDIA Volve</tradeName>
    <deviceName>Digital Mammography System</deviceName>
    <manufacturerName>DRTECH Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000012441</manufacturerSrn>
    <authorisedRepresentativeName>DRTECH Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011974</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AIDIA Volve-XS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T03:56:26.346Z</lastUpdated>
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    <udiDi>08800018423400</udiDi>
    <basicUdiDi>88000184SMXXXXXXXXBV</basicUdiDi>
    <tradeName>AIDIA Volve</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DRTECH Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000012441</manufacturerSrn>
    <authorisedRepresentativeName>DRTECH Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011974</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AIDIA Volve-XT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T03:47:56.729Z</lastUpdated>
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  <row>
    <udiDi>08800018423509</udiDi>
    <basicUdiDi>88000184SMXXXXXXXXBV</basicUdiDi>
    <tradeName>AIDIA Volve</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DRTECH Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000012441</manufacturerSrn>
    <authorisedRepresentativeName>DRTECH Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011974</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AIDIA Volve-HS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T03:47:53.293Z</lastUpdated>
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  <row>
    <udiDi>08800018423608</udiDi>
    <basicUdiDi>88000184SMXXXXXXXXBV</basicUdiDi>
    <tradeName>AIDIA Volve</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DRTECH Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000012441</manufacturerSrn>
    <authorisedRepresentativeName>DRTECH Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011974</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AIDIA Volve-HT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T03:47:27.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800018423202</udiDi>
    <basicUdiDi>88000184SMXXXXXXXXBV</basicUdiDi>
    <tradeName>AIDIA Nex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DRTECH Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000012441</manufacturerSrn>
    <authorisedRepresentativeName>DRTECH Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011974</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RMF-2000V</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T03:47:16.075Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938964317091</udiDi>
    <basicUdiDi>693896431700NY</basicUdiDi>
    <tradeName>06938964317091</tradeName>
    <deviceName>Digital Mammography Systems</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>MDR 2017/745</legislation>
    <emdnCode>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:38:01.514Z</lastUpdated>
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  <row>
    <udiDi>04056869124575</udiDi>
    <basicUdiDi>0405686901979WW</basicUdiDi>
    <tradeName>MAMMOMAT Revelation</tradeName>
    <deviceName>MDR_18_II b_ERLN H 127_Mammo_digital</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>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11343300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:38:35.604Z</lastUpdated>
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  <row>
    <udiDi>08800010320080</udiDi>
    <basicUdiDi>B-08800010320080</basicUdiDi>
    <tradeName>Digital Mammography X-ray system</tradeName>
    <deviceName>Pinkview-DR Plus</deviceName>
    <manufacturerName>BEMEMS CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000013634</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Pinkview-DR Plus</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:31:59.860Z</lastUpdated>
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    <udiDi>06950291110176</udiDi>
    <basicUdiDi>69502911MTQ</basicUdiDi>
    <tradeName>06950291110176</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sino Medical-Device Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007089</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Navigator Star Care</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-09T08:08:26.183Z</lastUpdated>
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    <udiDi>06950291110473</udiDi>
    <basicUdiDi>69502911DR3YB</basicUdiDi>
    <tradeName>06950291110473</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sino Medical-Device Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007089</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Navigator DR Care M</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-09T08:08:25.534Z</lastUpdated>
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    <udiDi>04630193910662</udiDi>
    <basicUdiDi>463019391HARMONIAW9</basicUdiDi>
    <tradeName>Harmonia DBT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDICAL TECHNOLOGIES Ltd</manufacturerName>
    <manufacturerSrn>RU-MF-000020612</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F0479E</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T14:00:29.122Z</lastUpdated>
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    <udiDi>04630193910723</udiDi>
    <basicUdiDi>463019391HARMONIAW9</basicUdiDi>
    <tradeName>Harmonia B</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDICAL TECHNOLOGIES Ltd</manufacturerName>
    <manufacturerSrn>RU-MF-000020612</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F0477E</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T14:00:29.029Z</lastUpdated>
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    <udiDi>06971576833054</udiDi>
    <basicUdiDi>B-06971576833054</basicUdiDi>
    <tradeName>06971576833054</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>MDD</legislation>
    <emdnCode>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80506485</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:06:22.366Z</lastUpdated>
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