<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-GBFEN-102bTV</udiDi>
    <basicUdiDi>B-GBFEN-102bTV</basicUdiDi>
    <tradeName>One Step Fentanyl Test Cassette (Urine)</tradeName>
    <deviceName>One Step Fentanyl Test Cassette (Urine)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090122</emdnCode>
    <emdnDescription>FENTANYL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBFEN-102b</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:17:34.868Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBFEN-101bTS</udiDi>
    <basicUdiDi>B-GBFEN-101bTS</basicUdiDi>
    <tradeName>One Step Fentanyl Test Strip (Urine)</tradeName>
    <deviceName>One Step Fentanyl Test Strip (Urine)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090122</emdnCode>
    <emdnDescription>FENTANYL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBFEN-101b</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:17:30.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FBFEN-102aSW</udiDi>
    <basicUdiDi>B-FBFEN-102aSW</basicUdiDi>
    <tradeName>Fentanyl Rapid Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName>Fentanyl Rapid Test Kit (Time-Resolved FIA)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090122</emdnCode>
    <emdnDescription>FENTANYL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FBFEN-102a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:17:34.885Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FBFEN-102aHGPE</udiDi>
    <basicUdiDi>B-FBFEN-102aHGPE</basicUdiDi>
    <tradeName>Fentanyl Rapid Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090122</emdnCode>
    <emdnDescription>FENTANYL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FBFEN-102a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:17:30.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566303421</udiDi>
    <basicUdiDi>B-06974566303421</basicUdiDi>
    <tradeName>Fentanyl (FYL) Rapid Test</tradeName>
    <deviceName>Fentanyl (FYL) Rapid Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090122</emdnCode>
    <emdnDescription>FENTANYL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DFY-105</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:56:53.548Z</lastUpdated>
  </row>
</eudamedExport>