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<eudamedExport entity="devices">
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    <basicUdiDi>69732628600303ZT</basicUdiDi>
    <tradeName>06941967218869</tradeName>
    <deviceName>Focusing Fluid</deviceName>
    <manufacturerName>Zybio Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000003349</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</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>01.09.1F.01.09.03</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:30:23.050Z</lastUpdated>
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    <udiDi>06903053068581</udiDi>
    <basicUdiDi>69449040AB760000364</basicUdiDi>
    <tradeName>Urine Sediment Calibrator</tradeName>
    <deviceName>Urine formed element control、Urine Sediment 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>W010106020602</emdnCode>
    <emdnDescription>URINE TESTING CALIBRATORS AND STANDARDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-043513-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:57:38.486Z</lastUpdated>
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    <udiDi>06942202226625</udiDi>
    <basicUdiDi>69422022W010106029901R0EG</basicUdiDi>
    <tradeName>Determinand Cleaning Liquid</tradeName>
    <deviceName>Determinand Cleaning Liquid</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060299</emdnCode>
    <emdnDescription>URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3024590</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:29:46.323Z</lastUpdated>
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  <row>
    <udiDi>06925794577269</udiDi>
    <basicUdiDi>69257945W0101060299R0QZ</basicUdiDi>
    <tradeName>Cleaning liquid (Concentrated type)</tradeName>
    <deviceName>Urinalysis Reagent</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060299</emdnCode>
    <emdnDescription>URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019971</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:28:05.565Z</lastUpdated>
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  <row>
    <udiDi>06925794576477</udiDi>
    <basicUdiDi>69257945W010106020302R0FD</basicUdiDi>
    <tradeName>Urine Sediment Analyzer Reagent Diluent</tradeName>
    <deviceName>Urinalysis Reagent</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010106020302</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3007269</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:27:58.364Z</lastUpdated>
  </row>
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    <udiDi>05404035100622</udiDi>
    <basicUdiDi>54040351CYDXStripsWH</basicUdiDi>
    <tradeName>CYDXStrips Urine 2GP</tradeName>
    <deviceName>CYDXStrips</deviceName>
    <manufacturerName>Cypress Diagnostics</manufacturerName>
    <manufacturerSrn>BE-MF-000000033</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060204</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Urine-2GP</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:59:12.195Z</lastUpdated>
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  <row>
    <udiDi>05404035100615</udiDi>
    <basicUdiDi>54040351CYDXStripsWH</basicUdiDi>
    <tradeName>CYDXStrips Urine 2GK</tradeName>
    <deviceName>CYDXStrips</deviceName>
    <manufacturerName>Cypress Diagnostics</manufacturerName>
    <manufacturerSrn>BE-MF-000000033</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060204</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Urine-2GK</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:50:40.531Z</lastUpdated>
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  <row>
    <udiDi>05404035100646</udiDi>
    <basicUdiDi>54040351URINE-2AC38</basicUdiDi>
    <tradeName>Urine 2AC</tradeName>
    <deviceName>Urine 2AC</deviceName>
    <manufacturerName>Cypress Diagnostics</manufacturerName>
    <manufacturerSrn>BE-MF-000000033</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060204</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Urine-2AC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:46:12.409Z</lastUpdated>
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  <row>
    <udiDi>05404035100608</udiDi>
    <basicUdiDi>54040351CYDXStripsWH</basicUdiDi>
    <tradeName>CYDXStrips Urine 10</tradeName>
    <deviceName>CYDXStrips</deviceName>
    <manufacturerName>Cypress Diagnostics</manufacturerName>
    <manufacturerSrn>BE-MF-000000033</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060204</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Urine-10</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:46:10.009Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DGHB-R102acro75</udiDi>
    <basicUdiDi>B-DGHB-R102acro75</basicUdiDi>
    <tradeName>GHB Rapid Test Cassette (Urine)</tradeName>
    <deviceName>GHB Rapid Test Cassette (Urine)</deviceName>
    <manufacturerName>Acro Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017832</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060201</emdnCode>
    <emdnDescription>URINE SINGLE TEST STRIPS (INCL. TABLETS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DGHB-R102</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:48:14.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DAT-111MY</udiDi>
    <basicUdiDi>B-DAT-111MY</basicUdiDi>
    <tradeName>Urine Adulteration Test Dipstick</tradeName>
    <deviceName>Urine Adulteration Test Dipstick</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060204</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DAT-111</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-29T23:30:28.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202235764</udiDi>
    <basicUdiDi>69422022W010106029901R0EG</basicUdiDi>
    <tradeName>Determinand Cleaning Liquid</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060299</emdnCode>
    <emdnDescription>URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3025938</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-27T11:08:44.964Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202236617</udiDi>
    <basicUdiDi>69422022W010106029901R0EG</basicUdiDi>
    <tradeName>Determinand Cleaning Liquid</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060299</emdnCode>
    <emdnDescription>URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3026095</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-27T11:08:44.944Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-300058LV</udiDi>
    <basicUdiDi>B-300058LV</basicUdiDi>
    <tradeName>MyTest Infection Urinarie</tradeName>
    <deviceName>MyTest Infection Urinarie</deviceName>
    <manufacturerName>PRIMA Lab SA</manufacturerName>
    <manufacturerSrn>CH-MF-000034473</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060204</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300058</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-25T11:48:05.452Z</lastUpdated>
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  <row>
    <udiDi>06941967218906</udiDi>
    <basicUdiDi>69732628600303ZT</basicUdiDi>
    <tradeName>06941967218906</tradeName>
    <deviceName>Focusing Fluid</deviceName>
    <manufacturerName>Zybio Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000003349</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.09.1F.01.09.04</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:08:36.648Z</lastUpdated>
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    <udiDi>04046681171727</udiDi>
    <basicUdiDi>4046681151040VR</basicUdiDi>
    <tradeName>Medi-Test Combi 2</tradeName>
    <deviceName>Medi-Test URYXXON® Stick 10</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>W0101060201</emdnCode>
    <emdnDescription>URINE SINGLE TEST STRIPS (INCL. TABLETS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>93015.004</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:58:41.596Z</lastUpdated>
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    <udiDi>62230182723286</udiDi>
    <basicUdiDi>B-62230182723286</basicUdiDi>
    <tradeName>Urine strips</tradeName>
    <deviceName>Urine strips</deviceName>
    <manufacturerName>Kalians Corporation</manufacturerName>
    <manufacturerSrn>EG-MF-000050142</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060205</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-795 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T01:47:55.523Z</lastUpdated>
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    <udiDi>62230182723118</udiDi>
    <basicUdiDi>B-62230182723118</basicUdiDi>
    <tradeName>Urine strips Reagent strips for urinalysis for ten parameters</tradeName>
    <deviceName>Urine strips Reagent strips for urinalysis for ten parameters</deviceName>
    <manufacturerName>Kalians Corporation</manufacturerName>
    <manufacturerSrn>EG-MF-000050142</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060205</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-795 002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T01:47:54.714Z</lastUpdated>
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    <udiDi>06935784460709</udiDi>
    <basicUdiDi>B-06935784460709</basicUdiDi>
    <tradeName>06935784460709</tradeName>
    <deviceName>Urine Microalbumin Creatinine  Ratio Test Kit (Fluorescence  Immunoassay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060299</emdnCode>
    <emdnDescription>URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S091</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-19T04:57:51.473Z</lastUpdated>
  </row>
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    <udiDi>D-CNMF000014455-BF-S095S4</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S095S4</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S095S4</tradeName>
    <deviceName>Urine Microalbumin Creatinine Ratio Test Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060299</emdnCode>
    <emdnDescription>URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S095</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:50:17.543Z</lastUpdated>
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</eudamedExport>