<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00850040712216</udiDi>
    <basicUdiDi>B-00850040712216</basicUdiDi>
    <tradeName>HemaSure</tradeName>
    <deviceName>HemaSure-OMICS Blood Stabilization Direct Draw Tube, 250 ul</deviceName>
    <manufacturerName>Mawi DNA Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023207</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0501010199</emdnCode>
    <emdnDescription>VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HemaSure-OMICS-250</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:01:48.832Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850040712209</udiDi>
    <basicUdiDi>B-00850040712209</basicUdiDi>
    <tradeName>HemaSure</tradeName>
    <deviceName>HemaSure-OMICS Blood Stabilization Direct Draw device, 9ml</deviceName>
    <manufacturerName>Mawi DNA Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023207</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0501010199</emdnCode>
    <emdnDescription>VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HemaSure-OMICS-9</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:01:48.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850040712193</udiDi>
    <basicUdiDi>B-00850040712193</basicUdiDi>
    <tradeName>HemaSure</tradeName>
    <deviceName>HemaSure-OMICS Blood Stabilization Direct Draw device, 6ml</deviceName>
    <manufacturerName>Mawi DNA Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023207</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0501010199</emdnCode>
    <emdnDescription>VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HemaSure-OMICS-6</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:01:44.027Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850040712186</udiDi>
    <basicUdiDi>B-00850040712186</basicUdiDi>
    <tradeName>HemaSure</tradeName>
    <deviceName>HemaSure-OMICS Blood Stabilization Direct Draw device, 3ml</deviceName>
    <manufacturerName>Mawi DNA Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023207</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0501010199</emdnCode>
    <emdnDescription>VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HemaSure-OMICS-3</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:01:43.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>20850040712258</udiDi>
    <basicUdiDi>85004071220850040712258RC</basicUdiDi>
    <tradeName>iSWAB</tradeName>
    <deviceName>iSWAB-Respiratory Tract Sample Collection Media-Extraction-Less Rack</deviceName>
    <manufacturerName>Mawi DNA Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023207</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IRC-T-EL-R</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:28:59.508Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850040712148</udiDi>
    <basicUdiDi>850040712001ISWAB-CELLSQU</basicUdiDi>
    <tradeName>iSWAB</tradeName>
    <deviceName>iSWAB Cells Collection Device</deviceName>
    <manufacturerName>Mawi DNA Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023207</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISWAB-CELLS-1200</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:24:17.427Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850040712100</udiDi>
    <basicUdiDi>850040712001iSWAB-MB3J</basicUdiDi>
    <tradeName>iSWAB</tradeName>
    <deviceName>iSWAB Microbiome Collection Device</deviceName>
    <manufacturerName>Mawi DNA Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023207</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iSWAB-MB-1200</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:24:15.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850040712087</udiDi>
    <basicUdiDi>850040712001ISWAB-RNA6H</basicUdiDi>
    <tradeName>iSWAB</tradeName>
    <deviceName>iSWAB RNA v2 Collection Device</deviceName>
    <manufacturerName>Mawi DNA Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023207</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISWAB-RNA-v2</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:24:13.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850040712056</udiDi>
    <basicUdiDi>850040712ISWAB-IDNR</basicUdiDi>
    <tradeName>iSWAB-ID</tradeName>
    <deviceName>iSWAB-ID Human DNA Collection Device</deviceName>
    <manufacturerName>Mawi DNA Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023207</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISWAB-ID-250</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:24:11.820Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850040712049</udiDi>
    <basicUdiDi>850040712001ISWAB-DSC4W</basicUdiDi>
    <tradeName>iSWAB-Discovery</tradeName>
    <deviceName>iSWAB-Discovery Human DNA Collection Device</deviceName>
    <manufacturerName>Mawi DNA Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023207</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISWAB-DSC</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:24:11.119Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850040712001</udiDi>
    <basicUdiDi>850040712001ISWAB-DNA4B</basicUdiDi>
    <tradeName>iSWAB</tradeName>
    <deviceName>iSWAB DNA Collection Device</deviceName>
    <manufacturerName>Mawi DNA Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023207</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISWAB-DNA-1200</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:24:08.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850040712018</udiDi>
    <basicUdiDi>850040712001ISWAB-DNA4B</basicUdiDi>
    <tradeName>iSWAB</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mawi DNA Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023207</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISD-T-1200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:44:25.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850040712025</udiDi>
    <basicUdiDi>850040712001ISWAB-DNA4B</basicUdiDi>
    <tradeName>iSWAB DNA Collection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mawi DNA Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023207</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISWAB-DNA-250</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:44:25.296Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850040712032</udiDi>
    <basicUdiDi>850040712001ISWAB-DNA4B</basicUdiDi>
    <tradeName>iSWAB</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mawi DNA Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023207</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISD-T-250</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:44:25.275Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850040712070</udiDi>
    <basicUdiDi>850040712001ISWAB-DSC4W</basicUdiDi>
    <tradeName>iSWAB-Discovery Human DNA Collection Tube</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mawi DNA Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023207</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISF-T-DSC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:44:25.220Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850040712094</udiDi>
    <basicUdiDi>850040712001ISWAB-RNA6H</basicUdiDi>
    <tradeName>iSWAB</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mawi DNA Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023207</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISR2-T-1200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:44:25.174Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850040712117</udiDi>
    <basicUdiDi>850040712001iSWAB-MB3J</basicUdiDi>
    <tradeName>iSWAB</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mawi DNA Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023207</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iSWAB-MBF-1200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:44:25.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850040712124</udiDi>
    <basicUdiDi>850040712001iSWAB-MB3J</basicUdiDi>
    <tradeName>iSWAB</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mawi DNA Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023207</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISM-T-1200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:44:25.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850040712131</udiDi>
    <basicUdiDi>850040712001iSWAB-MB3J</basicUdiDi>
    <tradeName>iSWAB</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mawi DNA Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023207</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISM-T-EL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:44:25.121Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850040712155</udiDi>
    <basicUdiDi>850040712001ISWAB-CELLSQU</basicUdiDi>
    <tradeName>iSWAB</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mawi DNA Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023207</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISC-T-1200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:44:25.094Z</lastUpdated>
  </row>
</eudamedExport>