<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-69750225320175CEL5S6</udiDi>
    <basicUdiDi>B-69750225320175CEL5S6</basicUdiDi>
    <tradeName>D-69750225320175CEL5S6</tradeName>
    <deviceName>Creatinine Test Strips</deviceName>
    <manufacturerName>EAGLENOS SCIENCES, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000036801</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060112</emdnCode>
    <emdnDescription>CREATININE ANALYSIS TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iCR 10,iCR 11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:17:09.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69750225320174CEKYTW</udiDi>
    <basicUdiDi>B-69750225320174CEKYTW</basicUdiDi>
    <tradeName>D-69750225320174CEKYTW</tradeName>
    <deviceName>Blood Uric Acid Test Strips</deviceName>
    <manufacturerName>EAGLENOS SCIENCES, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000036801</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EN400R1、EN400R2、 EN400R3、EN400R4、</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:17:08.279Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69750225320171CEKHRT</udiDi>
    <basicUdiDi>B-69750225320171CEKHRT</basicUdiDi>
    <tradeName>D-69750225320171CEKHRT</tradeName>
    <deviceName>Blood Lactate Test Strips</deviceName>
    <manufacturerName>EAGLENOS SCIENCES, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000036801</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060104</emdnCode>
    <emdnDescription>LACTATE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EN300R1、EN300R2、EN300R3、EN300R4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:17:02.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69750225320121CEJEPH</udiDi>
    <basicUdiDi>B-69750225320121CEJEPH</basicUdiDi>
    <tradeName>D-69750225320121CEJEPH</tradeName>
    <deviceName>Blood Gas Test Cartridges</deviceName>
    <manufacturerName>EAGLENOS SCIENCES, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000036801</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>see the instructions for use</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:17:02.134Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69750225319171CENMX2</udiDi>
    <basicUdiDi>B-69750225319171CENMX2</basicUdiDi>
    <tradeName>D-69750225319171CENMX2</tradeName>
    <deviceName>Blood Glucose Test Strips</deviceName>
    <manufacturerName>EAGLENOS SCIENCES, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000036801</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EN200R1、EN200R2、EN200R3、EN200R4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:17:01.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69750225319172CENSXR</udiDi>
    <basicUdiDi>B-69750225319172CENSXR</basicUdiDi>
    <tradeName>D-69750225319172CENSXR</tradeName>
    <deviceName>Blood β-Ketone Test Strips</deviceName>
    <manufacturerName>EAGLENOS SCIENCES, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000036801</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060110</emdnCode>
    <emdnDescription>KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EN500R1、EN500R2、 EN500R3、 EN500R4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:17:00.730Z</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>D-697424646PH001GSKD</udiDi>
    <basicUdiDi>B-697424646PH001GSKD</basicUdiDi>
    <tradeName>BV pH Rapid Test</tradeName>
    <deviceName>BV pH Rapid Test</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>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PH-6011/PH-6012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:14:31.653Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646PH000GQK4</udiDi>
    <basicUdiDi>B-697424646PH000GQK4</basicUdiDi>
    <tradeName>BV pH Rapid Test Kit</tradeName>
    <deviceName>BV pH Rapid Test Kit</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>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PH-6011/PH-6012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:14:29.521Z</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-697424646MVA001MF33</udiDi>
    <basicUdiDi>B-697424646MVA001MF33</basicUdiDi>
    <tradeName>Vaginitis Multi-Test(Swab)</tradeName>
    <deviceName>Vaginitis Multi-Test(Swab)</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>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MVA-6**1C/MVA-6**2C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:10:02.555Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646MVA000MD2S</udiDi>
    <basicUdiDi>B-697424646MVA000MD2S</basicUdiDi>
    <tradeName>Vaginitis Multi-test Kit</tradeName>
    <deviceName>Vaginitis Multi-test Kit</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>Share info GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005132</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MVA-6**1C/MVA-6**2C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:10:01.376Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646FOB000FKQ5Q</udiDi>
    <basicUdiDi>B-697424646FOB000FKQ5Q</basicUdiDi>
    <tradeName>Fecal Occult Blood FIA Test (Feces)</tradeName>
    <deviceName>Fecal Occult Blood FIA Test (Feces)</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>W0101060399</emdnCode>
    <emdnDescription>FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FOB-5012F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:06:02.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646FOB000GCSL</udiDi>
    <basicUdiDi>B-697424646FOB000GCSL</basicUdiDi>
    <tradeName>Faecal Occult Blood Rapid Test Kit(Feces)</tradeName>
    <deviceName>Faecal Occult Blood Rapid Test Kit(Feces)</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>W0101060399</emdnCode>
    <emdnDescription>FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FOB-5011/FOB-5012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:06:02.438Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646ALC003DPPF</udiDi>
    <basicUdiDi>B-697424646ALC003DPPF</basicUdiDi>
    <tradeName>Alcohol Rapid Test(Milk)</tradeName>
    <deviceName>Alcohol Rapid Test(Milk)</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>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ALC-8011/ALC-8012/ALC-8014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:02:49.134Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646ALC002DMP4</udiDi>
    <basicUdiDi>B-697424646ALC002DMP4</basicUdiDi>
    <tradeName>Alcohol Rapid Test(Saliva)</tradeName>
    <deviceName>Alcohol Rapid Test(Saliva)</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>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ALC-7011/ALC-7012/ALC-7014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:02:48.153Z</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-697424646ALC(S)000DHTJ</udiDi>
    <basicUdiDi>B-697424646ALC(S)000DHTJ</basicUdiDi>
    <tradeName>Alcohol Rapid Test Kit(Saliva)</tradeName>
    <deviceName>Alcohol Rapid Test Kit(Saliva)</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>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ALC-7011/ALC-7014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:02:42.028Z</lastUpdated>
  </row>
</eudamedExport>