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<eudamedExport entity="devices">
  <row>
    <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>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-S094S2</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S094S2</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S094S2</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-S094</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:50:12.963Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-S093RY</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S093RY</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S093RY</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-S093</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:50:12.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-S092RW</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-S092RW</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-S092RW</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-S092</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:50:07.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C093NG</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C093NG</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C093NG</tradeName>
    <deviceName>ACR Control</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>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-C093</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:44:48.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C092NE</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C092NE</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C092NE</tradeName>
    <deviceName>ACR Control</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>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-C092</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:44:46.147Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455-BF-C091NC</udiDi>
    <basicUdiDi>B-CNMF000014455-BF-C091NC</basicUdiDi>
    <tradeName>D-CNMF000014455-BF-C091NC</tradeName>
    <deviceName>ACR Control</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>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-C091</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:44:44.755Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646URS001T9CW</udiDi>
    <basicUdiDi>B-697424646URS001T9CW</basicUdiDi>
    <tradeName>Urine Analysis Test (Urine)</tradeName>
    <deviceName>Urine Analysis Test (Urine)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000051497</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060204</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>URS-1**1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:16:13.605Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646URS000T7CM</udiDi>
    <basicUdiDi>B-697424646URS000T7CM</basicUdiDi>
    <tradeName>Urine Analysis Test Strip(Urine)</tradeName>
    <deviceName>Urine Analysis Test Strip(Urine)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060204</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>URS-1111</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:16:13.319Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840309294</udiDi>
    <basicUdiDi>B-69743840309294</basicUdiDi>
    <tradeName>Urine strip test</tradeName>
    <deviceName>Urine strip test</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060204</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3034502</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:11:40.308Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646ALC001DKNT</udiDi>
    <basicUdiDi>B-697424646ALC001DKNT</basicUdiDi>
    <tradeName>Alcohol Rapid Test(Urine)</tradeName>
    <deviceName>Alcohol Rapid Test(Urine)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000051497</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060299</emdnCode>
    <emdnDescription>URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ALC-1011/ALC-1012/ALC-1014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:02:47.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646ALC000DHNG</udiDi>
    <basicUdiDi>B-697424646ALC000DHNG</basicUdiDi>
    <tradeName>Alcohol Rapid Test Kit(Urine)</tradeName>
    <deviceName>Alcohol Rapid Test Kit(Urine)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060299</emdnCode>
    <emdnDescription>URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ALC-1011/ALC-1012/ALC-1014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:02:46.679Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646ADU001ERSE</udiDi>
    <basicUdiDi>B-697424646ADU001ERSE</basicUdiDi>
    <tradeName>Urine Adulteration(ADU) Test (Urine)</tradeName>
    <deviceName>Urine Adulteration(ADU) Test (Urine)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000051497</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060204</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADU-1061</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:02:26.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646ADU000EPS5</udiDi>
    <basicUdiDi>B-697424646ADU000EPS5</basicUdiDi>
    <tradeName>Urine Adulteration Test (Urine)</tradeName>
    <deviceName>Urine Adulteration Test (Urine)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060204</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADU-1061</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:02:24.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757990URS25</udiDi>
    <basicUdiDi>B-693757990URS25</basicUdiDi>
    <tradeName>Urinalysis Reagent Strips</tradeName>
    <deviceName>Urinalysis Reagent Strips</deviceName>
    <manufacturerName>Nantong EgensBiotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021561</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060299</emdnCode>
    <emdnDescription>URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Urinalysis reagent strip</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:49:08.645Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693748520UX</udiDi>
    <basicUdiDi>B-693748520UX</basicUdiDi>
    <tradeName>ACCU-ANSWER</tradeName>
    <deviceName>Urinary Analysis Test Strips</deviceName>
    <manufacturerName>Guilin Zhonghui Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038423</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060201</emdnCode>
    <emdnDescription>URINE SINGLE TEST STRIPS (INCL. TABLETS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Uric 10 CF, Uric 4VSG, Uric 2VGK, Uric 2VGP, Uric 3V, Uric 4V</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:48:34.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693748520-UGPD</udiDi>
    <basicUdiDi>B-693748520-UGPD</basicUdiDi>
    <tradeName>ACCU-ANSWER</tradeName>
    <deviceName>Urine Glucose Test Strips</deviceName>
    <manufacturerName>Guilin Zhonghui Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038423</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060201</emdnCode>
    <emdnDescription>URINE SINGLE TEST STRIPS (INCL. TABLETS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Uric</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:48:34.389Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230041041216</udiDi>
    <basicUdiDi>B-62230041041216</basicUdiDi>
    <tradeName>Uritrak - 1,2,3, 5 and 10</tradeName>
    <deviceName>Uritrak - 1,2,3, 5 and 10</deviceName>
    <manufacturerName>Egyptian Company For Biotechnology-Spectrum Diagnostics</manufacturerName>
    <manufacturerSrn>EG-MF-000032599</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060204</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1100 100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:29:09.658Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230041041148</udiDi>
    <basicUdiDi>B-62230041041148</basicUdiDi>
    <tradeName>Uritrak - 1,2,3, 5 and 10</tradeName>
    <deviceName>Uritrak - 1,2,3, 5 and 10</deviceName>
    <manufacturerName>Egyptian Company For Biotechnology-Spectrum Diagnostics</manufacturerName>
    <manufacturerSrn>EG-MF-000032599</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060204</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1100 050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:29:05.404Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230041041070</udiDi>
    <basicUdiDi>B-62230041041070</basicUdiDi>
    <tradeName>Uritrak - 1,2,3, 5 and 10</tradeName>
    <deviceName>Uritrak - 1,2,3, 5 and 10</deviceName>
    <manufacturerName>Egyptian Company For Biotechnology-Spectrum Diagnostics</manufacturerName>
    <manufacturerSrn>EG-MF-000032599</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060204</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1100 030</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:29:04.433Z</lastUpdated>
  </row>
</eudamedExport>