<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00850521006018</udiDi>
    <basicUdiDi>B-00850521006018</basicUdiDi>
    <tradeName>DxCollect MicroCollection Device (MCD)</tradeName>
    <deviceName>DxCollect MicroCollection Device</deviceName>
    <manufacturerName>DxTerity Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029372</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0501010202</emdnCode>
    <emdnDescription>CAPILLARY AND VENOUS BLOOD COLLECTION, INTEGRATED SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100-000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:09:43.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850521006001</udiDi>
    <basicUdiDi>B-00850521006001</basicUdiDi>
    <tradeName>DxCollect Blood Collection Tube (BCT)</tradeName>
    <deviceName>DxCollect Blood Collection Tube</deviceName>
    <manufacturerName>DxTerity Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029372</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W050101010101</emdnCode>
    <emdnDescription>BLOOD COLLECTION, CLOSED SYRINGES WITH ADDITIVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>454361</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:09:43.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850057585100</udiDi>
    <basicUdiDi>B-00850057585100</basicUdiDi>
    <tradeName>TAP</tradeName>
    <deviceName>TAP Micro Select</deviceName>
    <manufacturerName>YourBio Health Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000040029</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>W0501010201</emdnCode>
    <emdnDescription>CAPILLARY BLOOD COLLECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>770102</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:03:50.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850057585063</udiDi>
    <basicUdiDi>B-00850057585063</basicUdiDi>
    <tradeName>TAP</tradeName>
    <deviceName>TAP Micro Blood Collection Device - Serum Gel CE</deviceName>
    <manufacturerName>YourBio Health Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000040029</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>W0501010201</emdnCode>
    <emdnDescription>CAPILLARY BLOOD COLLECTION SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>773102</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:03:49.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850057585049</udiDi>
    <basicUdiDi>B-00850057585049</basicUdiDi>
    <tradeName>TAP</tradeName>
    <deviceName>TAP Micro Blood Collection Device - Serum CE</deviceName>
    <manufacturerName>YourBio Health Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000040029</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>W0501010201</emdnCode>
    <emdnDescription>CAPILLARY BLOOD COLLECTION SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>773112</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:03:45.806Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850057585025</udiDi>
    <basicUdiDi>B-00850057585025</basicUdiDi>
    <tradeName>TAP</tradeName>
    <deviceName>TAP Micro Blood Collection Device - LiHep Gel CE</deviceName>
    <manufacturerName>YourBio Health Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000040029</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>W0501010201</emdnCode>
    <emdnDescription>CAPILLARY BLOOD COLLECTION SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>771212</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:03:44.997Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850057585001</udiDi>
    <basicUdiDi>B-00850057585001</basicUdiDi>
    <tradeName>TAP</tradeName>
    <deviceName>TAP Micro Blood Collection Device - LiHep CE</deviceName>
    <manufacturerName>YourBio Health Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000040029</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>W0501010201</emdnCode>
    <emdnDescription>CAPILLARY BLOOD COLLECTION SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>771202</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:03:44.192Z</lastUpdated>
  </row>
  <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>08809975010401</udiDi>
    <basicUdiDi>9975010371DL</basicUdiDi>
    <tradeName>cobas IGRA TB tubes</tradeName>
    <deviceName>cobas IGRA TB tubes</deviceName>
    <manufacturerName>Invitros Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000023980</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050101010201</emdnCode>
    <emdnDescription>BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09989978190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:26:49.670Z</lastUpdated>
  </row>
  <row>
    <udiDi>09555240401526</udiDi>
    <basicUdiDi>955524040ACNSED</basicUdiDi>
    <tradeName>SampLok® Adapter Cap 3</tradeName>
    <deviceName>Adapter Cap</deviceName>
    <manufacturerName>ITL Asia Pacific Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001570</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010180</emdnCode>
    <emdnDescription>VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A100760</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:19:31.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>09338799099907</udiDi>
    <basicUdiDi>93387990MITRA3X</basicUdiDi>
    <tradeName>09338799099907</tradeName>
    <deviceName>10uL Mitra Device (4-sampler) Collection Kit, OM Blue, EA</deviceName>
    <manufacturerName>Trajan Scientific Australia Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-PR-000033927</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W0501010299</emdnCode>
    <emdnDescription>CAPILLARY BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VM-104KMBD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:04:38.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906206830231</udiDi>
    <basicUdiDi>906206830DUVACB4</basicUdiDi>
    <tradeName>CLOT ACTIVATOR (Serum separator)- CAT</tradeName>
    <deviceName>BLOOD COLLECTION TUBE</deviceName>
    <manufacturerName>DUSONS MEDICARE LLP</manufacturerName>
    <manufacturerSrn>IN-MF-000049646</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050101010201</emdnCode>
    <emdnDescription>BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Closure Colour Code- Red</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:43:05.897Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975387351370</udiDi>
    <basicUdiDi>697538735VBCTUP</basicUdiDi>
    <tradeName>06975387351370</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHANDONG CHENGWU HUABO MEDICAL EQUIPMENT CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000055916</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050101010201</emdnCode>
    <emdnDescription>BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Plain Tube-PET 2ml</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:48:08.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975387351554</udiDi>
    <basicUdiDi>697538735VBCTUP</basicUdiDi>
    <tradeName>06975387351554</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHANDONG CHENGWU HUABO MEDICAL EQUIPMENT CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000055916</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050101010201</emdnCode>
    <emdnDescription>BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Heparin Sodium-PET 10ml</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:48:08.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975387351547</udiDi>
    <basicUdiDi>697538735VBCTUP</basicUdiDi>
    <tradeName>06975387351547</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHANDONG CHENGWU HUABO MEDICAL EQUIPMENT CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000055916</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050101010201</emdnCode>
    <emdnDescription>BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Heparin Sodium-PET 9ml</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:48:08.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975387351530</udiDi>
    <basicUdiDi>697538735VBCTUP</basicUdiDi>
    <tradeName>06975387351530</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHANDONG CHENGWU HUABO MEDICAL EQUIPMENT CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000055916</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050101010201</emdnCode>
    <emdnDescription>BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Heparin Sodium-PET 8ml</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:48:08.470Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975387351523</udiDi>
    <basicUdiDi>697538735VBCTUP</basicUdiDi>
    <tradeName>06975387351523</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHANDONG CHENGWU HUABO MEDICAL EQUIPMENT CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000055916</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050101010201</emdnCode>
    <emdnDescription>BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Heparin Sodium-PET 7ml</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:48:08.348Z</lastUpdated>
  </row>
</eudamedExport>