<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05061107470009</udiDi>
    <basicUdiDi>5061107470009R6</basicUdiDi>
    <tradeName>05061107470009</tradeName>
    <deviceName>Inuvi-002/CE Collection Kit</deviceName>
    <manufacturerName>Inuvi Health Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000057167</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Inuvi-002/CE</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:09:05.633Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060757350877</udiDi>
    <basicUdiDi>506075735W4000ZV</basicUdiDi>
    <tradeName>05060757350877</tradeName>
    <deviceName>Boots DNA Sample Collection Kit (Home Use – Single Test)</deviceName>
    <manufacturerName>Concepta Diagnostics</manufacturerName>
    <manufacturerSrn>GB-PR-000033063</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W4000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:53:32.251Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060757350082</udiDi>
    <basicUdiDi>506075735B7000TB</basicUdiDi>
    <tradeName>MyHealthChecked</tradeName>
    <deviceName>Blood &amp; Urine Sample Collection Kit (Home Use – Single Test)</deviceName>
    <manufacturerName>Concepta Diagnostics</manufacturerName>
    <manufacturerSrn>GB-PR-000033063</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B7000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:53:08.999Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060757350075</udiDi>
    <basicUdiDi>506075735D3000T5</basicUdiDi>
    <tradeName>MyHealthChecked</tradeName>
    <deviceName>DNA Sample Collection Kit (Home Use – Single Test)</deviceName>
    <manufacturerName>Concepta Diagnostics</manufacturerName>
    <manufacturerSrn>GB-PR-000033063</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D3000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:53:04.987Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060169696310</udiDi>
    <basicUdiDi>5060169696310XP</basicUdiDi>
    <tradeName>IDS Calprotectin Extraction Device</tradeName>
    <deviceName>IDS Fluid Calprotectin Calibrator Set</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-AI26040</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:33:07.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273220025</udiDi>
    <basicUdiDi>50552732AUFSCKT054Q9</basicUdiDi>
    <tradeName>UNIVERSAL FAECAL SAMPLE COLLECTION KIT</tradeName>
    <deviceName>UNIVERSAL FAECAL SAMPLE COLLECTION KIT</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019001</emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCK10693</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:13:55.260Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273219876</udiDi>
    <basicUdiDi>50552732AHMSCKT057K9</basicUdiDi>
    <tradeName>Microbiome Home Sample Collection Kit</tradeName>
    <deviceName>Microbiome Home Sample Collection Kit</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019001</emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCK10665</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:13:53.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273219333</udiDi>
    <basicUdiDi>50552732AHSSCKT056NR</basicUdiDi>
    <tradeName>Home Saliva Collection Kit</tradeName>
    <deviceName>Home Saliva Collection Kit</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCK10654</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:13:41.628Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273217919</udiDi>
    <basicUdiDi>50552732ACONSTI017LZ</basicUdiDi>
    <tradeName>CONFIDANTE</tradeName>
    <deviceName>CONFIDANTE</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV3879</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:13:06.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987295636311</udiDi>
    <basicUdiDi>4987295BU003ZV</basicUdiDi>
    <tradeName>EXTEL HEMO・AUTO MC Collection Picker</tradeName>
    <deviceName>EXTEL HEMO・AUTO MC Collection Picker</deviceName>
    <manufacturerName>Canon Medical Diagnostics Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000020364</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019001</emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63631</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:32:36.312Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987274058608</udiDi>
    <basicUdiDi>4987274W05019001SCC007Z</basicUdiDi>
    <tradeName>Specimen Collection Container A</tradeName>
    <deviceName>Specimen Collection Container A</deviceName>
    <manufacturerName>Alfresa Pharma Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000008778</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019001</emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>905860</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:31:53.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987026212289</udiDi>
    <basicUdiDi>4987026TD-OCLBYU</basicUdiDi>
    <tradeName>OC-Light™ S FIT Sampling Bottles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019001</emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PH82</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:31:42.024Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987026130088</udiDi>
    <basicUdiDi>4987026TD-OCSBZH</basicUdiDi>
    <tradeName>OC-Auto Sampling Bottle 3 (VCPZ25)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019001</emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PZ25</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:31:38.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262502760004</udiDi>
    <basicUdiDi>426250276circadian-kit6H</basicUdiDi>
    <tradeName>TimeTeller® – Your Circadian Rhythm</tradeName>
    <deviceName>Saliva sampling and submission kit</deviceName>
    <manufacturerName>TimeTeller GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000044816</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4262502760004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:41:48.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262456220012</udiDi>
    <basicUdiDi>426245622VSKPEG</basicUdiDi>
    <tradeName>Novo Saliva Kit</tradeName>
    <deviceName>NOVO Saliva Kit</deviceName>
    <manufacturerName>Novogenia GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000038731</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VSKP</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:37:42.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262450880403</udiDi>
    <basicUdiDi>426245088stuhl8Q</basicUdiDi>
    <tradeName>Probenentnahmeset Stuhl</tradeName>
    <deviceName>Probenentnahmeset - Stuhl</deviceName>
    <manufacturerName>vivatura GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000042971</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W05019001</emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>stuhl</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:37:02.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262450880366</udiDi>
    <basicUdiDi>426245088urindbsCK</basicUdiDi>
    <tradeName>Probenentnahmeset Urin und Trockenblutkarte</tradeName>
    <deviceName>Probenentnahmeset - Urin und Trockenblutkarte</deviceName>
    <manufacturerName>vivatura GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000042971</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>urindbs</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:37:01.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262401270055</udiDi>
    <basicUdiDi>426240127PP-SWA-VA-HPVZT</basicUdiDi>
    <tradeName>04262401270055</tradeName>
    <deviceName>Vaginal Swab Sample Collection Kit</deviceName>
    <manufacturerName>DasLab GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000025410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4262401270055</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:31:22.913Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262401270031</udiDi>
    <basicUdiDi>426240127PP-STO-BLXQ</basicUdiDi>
    <tradeName>04262401270031</tradeName>
    <deviceName>Stool Sample Collection Kit</deviceName>
    <manufacturerName>DasLab GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000025410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W05019001</emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4262401270031</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:31:22.473Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260582940019</udiDi>
    <basicUdiDi>4260582944600YH</basicUdiDi>
    <tradeName>SAMPLING.pro</tradeName>
    <deviceName>SAMPLING.pro</deviceName>
    <manufacturerName>BIOMES NGS GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000042230</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>4600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T23:11:46.443Z</lastUpdated>
  </row>
</eudamedExport>