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<eudamedExport entity="devices">
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    <udiDi>06936415994761</udiDi>
    <basicUdiDi>69449040AB70000043Q</basicUdiDi>
    <tradeName>CRP Cleanser</tradeName>
    <deviceName>LC LYSE、CRP Cleanser</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-011300-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:42:03.398Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415988401</udiDi>
    <basicUdiDi>69449040AB3000005ZK</basicUdiDi>
    <tradeName>Automated Digital Cell Morphology Analyzer</tradeName>
    <deviceName>Automated Digital Cell Morphology Analyzer</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029099</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MC-80</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:42:02.595Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415986827</udiDi>
    <basicUdiDi>69449040004JIgE********W8</basicUdiDi>
    <tradeName>Immunoglobulin E Kit (Particle-enhanced Immunoturbidimetric Assay Method)</tradeName>
    <deviceName>Immunoglobulin E Kit (Particle-enhanced Immunoturbidimetric Assay Method)、IgE Calibrator</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-020853-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:42:01.790Z</lastUpdated>
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  <row>
    <udiDi>06936415986742</udiDi>
    <basicUdiDi>69449040AB050100315Q</basicUdiDi>
    <tradeName>06936415986742</tradeName>
    <deviceName>Remote Imaging System</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UltraSync</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:42:00.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415986476</udiDi>
    <basicUdiDi>69449040004EFUN********G8</basicUdiDi>
    <tradeName>FUN Control</tradeName>
    <deviceName>Fructosamine (FUN) Kit (Colorimetric Assay)、FUN Control</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-020477-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:42:00.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415986452</udiDi>
    <basicUdiDi>694490400046CO2TBACon**HL</basicUdiDi>
    <tradeName>CO2 and TBA Multi Control</tradeName>
    <deviceName>CO2 and TBA Multi Control</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-020476-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:58.593Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415986421</udiDi>
    <basicUdiDi>694490400043AFU********F3</basicUdiDi>
    <tradeName>AFU Control</tradeName>
    <deviceName>α-L-Fucosidase Kit (CNPF Method)、AFU Control</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-020474-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:57.788Z</lastUpdated>
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  <row>
    <udiDi>06936415979478</udiDi>
    <basicUdiDi>69449040AB0651000385</basicUdiDi>
    <tradeName>06936415979478</tradeName>
    <deviceName>Endoscope Light Source</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020402</emdnCode>
    <emdnDescription>LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB300R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:56.990Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415979430</udiDi>
    <basicUdiDi>69449040AB0651000283</basicUdiDi>
    <tradeName>06936415979430</tradeName>
    <deviceName>Endoscope Camera System</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020405</emdnCode>
    <emdnDescription>SURGICAL CAMERAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:56.194Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415977993</udiDi>
    <basicUdiDi>69449040AB050100135N</basicUdiDi>
    <tradeName>06936415977993</tradeName>
    <deviceName>Digital Ultrasonic Diagnostic Imaging System</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040103</emdnCode>
    <emdnDescription>PORTABLE ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP-10T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:55.396Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415977658</udiDi>
    <basicUdiDi>69449040AB400000629</basicUdiDi>
    <tradeName>Chemiluminescence Immunoassay Analyzer</tradeName>
    <deviceName>Chemiluminescence Immunoassay Analyzer</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020104</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput &gt; 700 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL-9000i</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:54.578Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415977092</udiDi>
    <basicUdiDi>69449040AB3000011ZE</basicUdiDi>
    <tradeName>Auto Hematology Analyzer</tradeName>
    <deviceName>Auto Hematology Analyzer</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BC-7500[B] CRP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:53.784Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415977054</udiDi>
    <basicUdiDi>69449040AB3000020ZF</basicUdiDi>
    <tradeName>Auto Hematology Analyzer</tradeName>
    <deviceName>Auto Hematology Analyzer</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BC-6600Plus</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:52.990Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415976941</udiDi>
    <basicUdiDi>69449040AB3000017ZS</basicUdiDi>
    <tradeName>Auto Hematology Analyzer</tradeName>
    <deviceName>Auto Hematology Analyzer</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BC-5100 CRP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:52.189Z</lastUpdated>
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  <row>
    <udiDi>06936415973704</udiDi>
    <basicUdiDi>69449040AB050100515W</basicUdiDi>
    <tradeName>06936415973704</tradeName>
    <deviceName>Digital Radiography System</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DigiEye 680</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:51.381Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415973599</udiDi>
    <basicUdiDi>69449040AB010000443J</basicUdiDi>
    <tradeName>06936415973599</tradeName>
    <deviceName>Vital Signs Monitor</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Vital Signs Monitor</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:50.578Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415972431</udiDi>
    <basicUdiDi>69449040AB010000063A</basicUdiDi>
    <tradeName>eGateway Integration Manager</tradeName>
    <deviceName>eGateway Integration Manager</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>eGateway</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:49.781Z</lastUpdated>
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  <row>
    <udiDi>06936415972417</udiDi>
    <basicUdiDi>69449040AB010000333D</basicUdiDi>
    <tradeName>Central Monitoring System</tradeName>
    <deviceName>Airway Adapter</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020201</emdnCode>
    <emdnDescription>MULTI–PARAMETER PATIENT BEDSIDE MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BeneVision</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:48.976Z</lastUpdated>
  </row>
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    <udiDi>06936415972080</udiDi>
    <basicUdiDi>69449040AB050100115J</basicUdiDi>
    <tradeName>06936415972080</tradeName>
    <deviceName>Diagnostic Ultrasound System</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040104</emdnCode>
    <emdnDescription>MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC-20 Exp</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:48.183Z</lastUpdated>
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    <udiDi>06936415971960</udiDi>
    <basicUdiDi>69449040AB065100017Z</basicUdiDi>
    <tradeName>06936415971960</tradeName>
    <deviceName>Endoscope Camera System</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12020405</emdnCode>
    <emdnDescription>SURGICAL CAMERAS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:41:47.379Z</lastUpdated>
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</eudamedExport>