<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-697177120136896</udiDi>
    <basicUdiDi>B-697177120136896</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Propoxyphene(PPX) 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>W0102090115</emdnCode>
    <emdnDescription>PROPOXYPHENE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PPX-U11（25PCS）</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:58:24.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414595948</udiDi>
    <basicUdiDi>0405686901764W7</basicUdiDi>
    <tradeName>Atellica CH Propoxyphene (Ppx)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_PPX_2</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090115</emdnCode>
    <emdnDescription>PROPOXYPHENE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097519</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:34:46.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768001918</udiDi>
    <basicUdiDi>0405686901169VK</basicUdiDi>
    <tradeName>Emit II Plus Propoxyphene Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_Propoxyphene Assay</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090115</emdnCode>
    <emdnDescription>PROPOXYPHENE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445433</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:28:36.113Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768001925</udiDi>
    <basicUdiDi>0405686901169VK</basicUdiDi>
    <tradeName>Emit II Plus Propoxyphene Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090115</emdnCode>
    <emdnDescription>PROPOXYPHENE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445435</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:43.999Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768014383</udiDi>
    <basicUdiDi>0405686901169VK</basicUdiDi>
    <tradeName>Emit II Plus Propoxyphene Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090115</emdnCode>
    <emdnDescription>PROPOXYPHENE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445434</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:38.367Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-475027QF</udiDi>
    <basicUdiDi>B-475027QF</basicUdiDi>
    <tradeName>Propoxyphene Reagent (PROX 1 x 250)</tradeName>
    <deviceName>Propoxyphene Reagent (PROX 1 x 250)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090115</emdnCode>
    <emdnDescription>PROPOXYPHENE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>475027</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:05:59.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548251749</udiDi>
    <basicUdiDi>B-08683548251749</basicUdiDi>
    <tradeName>DrugFor™ Propoxyphene (PPX) Rapid Test Kit (Urine)</tradeName>
    <deviceName>Propoxyphene (PPX) Rapid Test Kit (Urine)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090115</emdnCode>
    <emdnDescription>PROPOXYPHENE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VDDOA26</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:13:08.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548251459</udiDi>
    <basicUdiDi>B-08683548251459</basicUdiDi>
    <tradeName>RapidFor™ Propoxyphene (PPX) Rapid Test Kit (Urine)</tradeName>
    <deviceName>Propoxyphene (PPX) Rapid Test Kit (Urine)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090115</emdnCode>
    <emdnDescription>PROPOXYPHENE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VDOA26</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:12:21.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976202761329</udiDi>
    <basicUdiDi>B-06976202761329</basicUdiDi>
    <tradeName>Propoxyphene (PPX) Rapid Test</tradeName>
    <deviceName>Propoxyphene (PPX) Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090115</emdnCode>
    <emdnDescription>PROPOXYPHENE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GDPPX-A102</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:33:38.212Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566302981</udiDi>
    <basicUdiDi>B-06974566302981</basicUdiDi>
    <tradeName>Propoxyphene (PPX) Rapid Test</tradeName>
    <deviceName>Propoxyphene (PPX) 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>W0102090115</emdnCode>
    <emdnDescription>PROPOXYPHENE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DPP-105</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:54:01.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974473308038</udiDi>
    <basicUdiDi>B-06974473308038</basicUdiDi>
    <tradeName>PPX Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>PPX Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090115</emdnCode>
    <emdnDescription>PROPOXYPHENE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP022</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:12:02.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883012899</udiDi>
    <basicUdiDi>B-00884883012899</basicUdiDi>
    <tradeName>00884883012899</tradeName>
    <deviceName>DRI Propoxyphene Assay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090115</emdnCode>
    <emdnDescription>PROPOXYPHENE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10018510</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:32:20.044Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883008892</udiDi>
    <basicUdiDi>B-00884883008892</basicUdiDi>
    <tradeName>00884883008892</tradeName>
    <deviceName>Alinity c Propoxyphene</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090115</emdnCode>
    <emdnDescription>PROPOXYPHENE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09P8720</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:29:11.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883008403</udiDi>
    <basicUdiDi>B-00884883008403</basicUdiDi>
    <tradeName>00884883008403</tradeName>
    <deviceName>ARCHITECT Propoxyphene</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090115</emdnCode>
    <emdnDescription>PROPOXYPHENE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6L97-20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:28:18.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883004351</udiDi>
    <basicUdiDi>B-00884883004351</basicUdiDi>
    <tradeName>00884883004351</tradeName>
    <deviceName>CEDIA Propoxyphene LC</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090115</emdnCode>
    <emdnDescription>PROPOXYPHENE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1661523</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:19:59.836Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883004283</udiDi>
    <basicUdiDi>B-00884883004283</basicUdiDi>
    <tradeName>00884883004283</tradeName>
    <deviceName>CEDIA Propoxyphene Assay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090115</emdnCode>
    <emdnDescription>PROPOXYPHENE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100171</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:19:48.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883004221</udiDi>
    <basicUdiDi>B-00884883004221</basicUdiDi>
    <tradeName>00884883004221</tradeName>
    <deviceName>CEDIA Propoxyphene Assay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090115</emdnCode>
    <emdnDescription>PROPOXYPHENE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100170</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:19:39.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883003439</udiDi>
    <basicUdiDi>B-00884883003439</basicUdiDi>
    <tradeName>00884883003439</tradeName>
    <deviceName>DRI Propoxyphene Assay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090115</emdnCode>
    <emdnDescription>PROPOXYPHENE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0432</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:16:11.683Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883002975</udiDi>
    <basicUdiDi>B-00884883002975</basicUdiDi>
    <tradeName>00884883002975</tradeName>
    <deviceName>DRI Propoxyphene Assay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090115</emdnCode>
    <emdnDescription>PROPOXYPHENE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0433</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:15:58.062Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804817183</udiDi>
    <basicUdiDi>B-06952804817183</basicUdiDi>
    <tradeName>Propoxyphene Rapid Test</tradeName>
    <deviceName>Propoxyphene Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090115</emdnCode>
    <emdnDescription>PROPOXYPHENE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PPX-U11, PPX-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:30:40.930Z</lastUpdated>
  </row>
</eudamedExport>