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    <basicUdiDi>69357407IUCS000002QN</basicUdiDi>
    <tradeName>06935740723527</tradeName>
    <deviceName>Urinalysis Control</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</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>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:04:00.958Z</lastUpdated>
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    <udiDi>06935740713924</udiDi>
    <basicUdiDi>69357407IUSS00000229</basicUdiDi>
    <tradeName>URIT FC 23 Focusing Fluid for Urine Sediment Analyzer</tradeName>
    <deviceName>Focusing Fluid for Urine Sediment Analyzer</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</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>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:03:24.191Z</lastUpdated>
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    <udiDi>06935740713870</udiDi>
    <basicUdiDi>69357407IUSS0000112A</basicUdiDi>
    <tradeName>URIT QC 22 Control Material for Urine Sediment Analyzer</tradeName>
    <deviceName>Control Material for Urine Sediment Analyzer</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</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>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:03:22.495Z</lastUpdated>
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    <udiDi>04046681141683</udiDi>
    <basicUdiDi>4046681151897XW</basicUdiDi>
    <tradeName>URYXXON® Control Strip</tradeName>
    <deviceName>URYXXON® Control Strip</deviceName>
    <manufacturerName>MACHEREY-NAGEL GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005636</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010106020602</emdnCode>
    <emdnDescription>URINE TESTING CALIBRATORS AND STANDARDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>930988</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:16:55.176Z</lastUpdated>
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    <udiDi>04046681000607</udiDi>
    <basicUdiDi>4046681151033VU</basicUdiDi>
    <tradeName>Medi-Test Control</tradeName>
    <deviceName>Medi-Test Control</deviceName>
    <manufacturerName>MACHEREY-NAGEL GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005636</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>93038</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:16:36.690Z</lastUpdated>
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  <row>
    <udiDi>06903053070713</udiDi>
    <basicUdiDi>69449040AB760000364</basicUdiDi>
    <tradeName>Urine formed element control</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W010106020602</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-043948-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:15.197Z</lastUpdated>
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  <row>
    <udiDi>06903053070720</udiDi>
    <basicUdiDi>69449040AB760000364</basicUdiDi>
    <tradeName>Urine formed element control</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W010106020602</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-043951-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:15.182Z</lastUpdated>
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  <row>
    <udiDi>06903053070737</udiDi>
    <basicUdiDi>69449040AB760000364</basicUdiDi>
    <tradeName>Urine formed element control</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W010106020602</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-043950-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:15.169Z</lastUpdated>
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  <row>
    <udiDi>06903053070744</udiDi>
    <basicUdiDi>69449040AB760000364</basicUdiDi>
    <tradeName>Urine formed element control</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W010106020602</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-043949-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:15.155Z</lastUpdated>
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    <udiDi>08806125621937</udiDi>
    <basicUdiDi>88061256U513NC</basicUdiDi>
    <tradeName>URiTROR™ Liquid Level 1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>YD Diagnostics CORP.</manufacturerName>
    <manufacturerSrn>KR-MF-000023981</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U5-11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:20:01.686Z</lastUpdated>
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    <udiDi>08806125621944</udiDi>
    <basicUdiDi>88061256U513NC</basicUdiDi>
    <tradeName>URiTROL™ Liquid Level 2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>YD Diagnostics CORP.</manufacturerName>
    <manufacturerSrn>KR-MF-000023981</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U5-12</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:20:01.669Z</lastUpdated>
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  <row>
    <udiDi>06942202208959</udiDi>
    <basicUdiDi>B-06942202208959</basicUdiDi>
    <tradeName>Urinalysis Multi-Control</tradeName>
    <deviceName>Urinalysis Multi-Control</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3010243</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:51:28.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202208942</udiDi>
    <basicUdiDi>B-06942202208942</basicUdiDi>
    <tradeName>Urinalysis Multi-Control</tradeName>
    <deviceName>Urinalysis Multi-Control</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3010242</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:51:22.334Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202204340</udiDi>
    <basicUdiDi>B-06942202204340</basicUdiDi>
    <tradeName>H series urine analyzer Calibration liquid for Specific gravity</tradeName>
    <deviceName>H series urine analyzer Calibration liquid for Specific gravity</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020602</emdnCode>
    <emdnDescription>URINE TESTING CALIBRATORS AND STANDARDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3022357</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:51:18.732Z</lastUpdated>
  </row>
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    <udiDi>06942202204302</udiDi>
    <basicUdiDi>B-06942202204302</basicUdiDi>
    <tradeName>H series urine analyzer Control liquid for Specific gravity</tradeName>
    <deviceName>H series urine analyzer Control liquid for Specific gravity</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3022331</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:51:12.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202204296</udiDi>
    <basicUdiDi>B-06942202204296</basicUdiDi>
    <tradeName>H series urine analyzer Control liquid for Specific gravity</tradeName>
    <deviceName>H series urine analyzer Control liquid for Specific gravity</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3022339</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:51:11.537Z</lastUpdated>
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    <udiDi>06942202204289</udiDi>
    <basicUdiDi>B-06942202204289</basicUdiDi>
    <tradeName>H series urine analyzer Control liquid for Specific gravity</tradeName>
    <deviceName>H series urine analyzer Control liquid for Specific gravity</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3022314</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:51:10.657Z</lastUpdated>
  </row>
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    <udiDi>06942202204272</udiDi>
    <basicUdiDi>B-06942202204272</basicUdiDi>
    <tradeName>H series urine analyzer Color Control</tradeName>
    <deviceName>H series urine analyzer Color Control</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3022324</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:51:09.252Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202204265</udiDi>
    <basicUdiDi>B-06942202204265</basicUdiDi>
    <tradeName>H series urine analyzer Color Control</tradeName>
    <deviceName>H series urine analyzer Color Control</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3022348</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:51:03.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202204258</udiDi>
    <basicUdiDi>B-06942202204258</basicUdiDi>
    <tradeName>H series urine analyzer Color Control</tradeName>
    <deviceName>H series urine analyzer Color Control</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3022323</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:51:02.319Z</lastUpdated>
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