<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-697424646ACE001AWKB</udiDi>
    <basicUdiDi>B-697424646ACE001AWKB</basicUdiDi>
    <tradeName>Acetaminophen(ACE) Rapid Test(Urine)</tradeName>
    <deviceName>Acetaminophen(ACE) 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>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACE-1011/ACE-1012/ACE-1014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:01:59.997Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6974246466-MAM002D7XQ</udiDi>
    <basicUdiDi>B-6974246466-MAM002D7XQ</basicUdiDi>
    <tradeName>6-Monoacetylmorphine(6-MAM) Rapid Test(Saliva)</tradeName>
    <deviceName>6-Monoacetylmorphine(6-MAM) 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>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6-MAM-7011/6-MAM-7012/6-MAM-7014/6-MAM-7015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:01:52.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6974246466-MAM001D5XF</udiDi>
    <basicUdiDi>B-6974246466-MAM001D5XF</basicUdiDi>
    <tradeName>6-Monoacetylmorphine(6-MAM) Rapid Test(Urine)</tradeName>
    <deviceName>6-Monoacetylmorphine(6-MAM) 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>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6-MAM-1011/6-MAM-1012/6-MAM-1014/6-MAM-1015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:01:48.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6974246466-MAM000D3X6</udiDi>
    <basicUdiDi>B-6974246466-MAM000D3X6</basicUdiDi>
    <tradeName>6-Monoacetylmorphine(6-MAM) Rapid Test</tradeName>
    <deviceName>6-Monoacetylmorphine(6-MAM) Rapid Test</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>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6-MAM-1011/6-MAM-1012/6-MAM-7012/6-MAM-7014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:01:47.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69717712022358R</udiDi>
    <basicUdiDi>B-69717712022358R</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>One Step Multi-Drug Rapid Test(Urine)</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DOAP-112（25PCS）</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:00:35.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697177120163494</udiDi>
    <basicUdiDi>B-697177120163494</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Fentanyl (FYL) Rapid Test (Urine)</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FYL-U21（25PCS）</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:58:57.066Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69717712016108N</udiDi>
    <basicUdiDi>B-69717712016108N</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Methadone metabolite (EDDP) Rapid Test(Urine)</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160507</emdnCode>
    <emdnDescription>METHADONE INCL. EDDP - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EDDP-U21（25PCS）</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:58:56.599Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69717712015979P</udiDi>
    <basicUdiDi>B-69717712015979P</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Ketamine (KET) Rapid Test (Urine)</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KET-U21(25PCS)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:58:55.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697177120157399</udiDi>
    <basicUdiDi>B-697177120157399</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Marijuana (THC) Rapid Test (Urine)</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>THC-U21(25PCS)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:58:49.278Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697177120152894</udiDi>
    <basicUdiDi>B-697177120152894</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Methadone(MTD) Rapid Test (Urine)</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160507</emdnCode>
    <emdnDescription>METHADONE INCL. EDDP - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MDT-U21（25PCS）</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:58:49.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69717712015048N</udiDi>
    <basicUdiDi>B-69717712015048N</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Buprenorphine (BUP) Rapid Test (Urine)</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BUP-U21(25PCS)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:58:42.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69717712014989L</udiDi>
    <basicUdiDi>B-69717712014989L</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Methylenedioxymethamphetamine (MDMA) Rapid Test(Urine)</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160507</emdnCode>
    <emdnDescription>METHADONE INCL. EDDP - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MDMA-U21(25PCS)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:58:42.011Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697177120148193</udiDi>
    <basicUdiDi>B-697177120148193</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Methamphetamine (MET) Rapid Test (Urine)</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160502</emdnCode>
    <emdnDescription>AMPHETAMINE/METHAMPHETAMINE SPECIFIC (+ECSTASY) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MET-U21（25PCS）</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:58:41.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697177120147496</udiDi>
    <basicUdiDi>B-697177120147496</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Cocaine(COC) Rapid Test (Urine)</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160506</emdnCode>
    <emdnDescription>COCAINE + COCAINE METABOLITES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COC-U21(25PCS)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:58:35.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697177120146799</udiDi>
    <basicUdiDi>B-697177120146799</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Benzodiazepines (BZO) Rapid Test (Urine)</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160504</emdnCode>
    <emdnDescription>BENZODIAZEPINES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BZO-U21（25PCS）</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:58:33.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69717712014508Q</udiDi>
    <basicUdiDi>B-69717712014508Q</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Barbiturate (BAR) Rapid Test (Urine)</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160503</emdnCode>
    <emdnDescription>BARBITURATES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAR-U21（25PCS）</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:58:32.703Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69717712014368W</udiDi>
    <basicUdiDi>B-69717712014368W</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Amphetamine (AMP) Rapid Test (Urine)</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160501</emdnCode>
    <emdnDescription>AMPHETAMINES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMP-U11(25PCS)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:58:27.466Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69717712013828Y</udiDi>
    <basicUdiDi>B-69717712013828Y</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Tramadol(TRA) Rapid Test Device(Urine)</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRA-U11（25PCS）</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:58:26.663Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697177120137593</udiDi>
    <basicUdiDi>B-697177120137593</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Tricyclic Antidepressants (TCA) Rapid Test Device(Urine)</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160510</emdnCode>
    <emdnDescription>TRICYCLIC ANTIDEPRESSANTS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TCA-U11（25PCS）</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:58:25.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69717712013518M</udiDi>
    <basicUdiDi>B-69717712013518M</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Phencyclidine(PCP) Rapid Test Device(Urine)</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160509</emdnCode>
    <emdnDescription>PHENCYCLIDINE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCP-U11（25PCS）</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:58:18.683Z</lastUpdated>
  </row>
</eudamedExport>