<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>05060757350068</udiDi>
    <basicUdiDi>506075735B6000T4</basicUdiDi>
    <tradeName>MyHealthChecked</tradeName>
    <deviceName>Blood Sample Collection Kit – Gold &amp; Lavender Tube (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>W0501010201</emdnCode>
    <emdnDescription>CAPILLARY BLOOD COLLECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B6000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:53:04.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060757350051</udiDi>
    <basicUdiDi>506075735B5000SV</basicUdiDi>
    <tradeName>MyHealthChecked</tradeName>
    <deviceName>MyHealthChecked Blood Sample Collection Kit – Gold Tube (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>W0501010201</emdnCode>
    <emdnDescription>CAPILLARY BLOOD COLLECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B5000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:53:03.386Z</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>05055382306320</udiDi>
    <basicUdiDi>506013188TF6444</basicUdiDi>
    <tradeName>Alvita Specimen Container 60ML Pack of 10 [EN]</tradeName>
    <deviceName>Sample container</deviceName>
    <manufacturerName>Reliance Medical Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004799</manufacturerSrn>
    <authorisedRepresentativeName>Reliance Medical (Ireland)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003675</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05010203</emdnCode>
    <emdnDescription>URINE COLLECTION, CONTAINERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ALV5399</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:31:08.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273220292</udiDi>
    <basicUdiDi>50552732ACBSCKD0615C</basicUdiDi>
    <tradeName>Capillary Blood Sample Collection Kit D</tradeName>
    <deviceName>Capillary Blood Sample Collection Kit D</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>W0501010201</emdnCode>
    <emdnDescription>CAPILLARY BLOOD COLLECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCK10719</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:14:05.645Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273220179</udiDi>
    <basicUdiDi>50552732ACBSCKC06053</basicUdiDi>
    <tradeName>Capillary Blood Sample Collection Kit C</tradeName>
    <deviceName>VENOUS BLOOD 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>W0501010201</emdnCode>
    <emdnDescription>CAPILLARY BLOOD COLLECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCK10674</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:14:02.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273220155</udiDi>
    <basicUdiDi>50552732ACBSCKA05852</basicUdiDi>
    <tradeName>Capillary Blood Sample Collection Kit A</tradeName>
    <deviceName>Capillary Blood Sample Collection Kit A</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>W0501010201</emdnCode>
    <emdnDescription>CAPILLARY BLOOD COLLECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCK10672</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:14:00.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273220148</udiDi>
    <basicUdiDi>50552732ACBSCKB0595B</basicUdiDi>
    <tradeName>Capillary Blood Sample Collection Kit B</tradeName>
    <deviceName>Capillary Blood Sample Collection Kit B</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>W0501010201</emdnCode>
    <emdnDescription>CAPILLARY BLOOD COLLECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCK10673</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:14:00.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273220032</udiDi>
    <basicUdiDi>50552732AVBSCKT055NN</basicUdiDi>
    <tradeName>VENOUS BLOOD SAMPLE COLLECTION KIT 1</tradeName>
    <deviceName>VENOUS BLOOD 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>W0501010199</emdnCode>
    <emdnDescription>VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCK10694</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:13:59.244Z</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>05055273219807</udiDi>
    <basicUdiDi>50552732ACAPCOL05167</basicUdiDi>
    <tradeName>Premium Capillary Blood Sample Collection Kit</tradeName>
    <deviceName>Premium Capillary Blood 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>W0501010201</emdnCode>
    <emdnDescription>CAPILLARY BLOOD COLLECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCK10677</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:13:48.841Z</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>05055273218879</udiDi>
    <basicUdiDi>50552732ACTSCKT047KQ</basicUdiDi>
    <tradeName>ConcizuTrace™ Sample Collection Kit</tradeName>
    <deviceName>ConcizuTrace™ 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>W0501010199</emdnCode>
    <emdnDescription>VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CZM10594</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:13:34.434Z</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>05055273217254</udiDi>
    <basicUdiDi>50552732AHBLSCK042AD</basicUdiDi>
    <tradeName>Home Blood Sample Collection Kit</tradeName>
    <deviceName>Home Blood 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>W0501010201</emdnCode>
    <emdnDescription>CAPILLARY BLOOD COLLECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV4460</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:13:04.189Z</lastUpdated>
  </row>
  <row>
    <udiDi>05018632288999</udiDi>
    <basicUdiDi>5018632RECEPTACLES006M</basicUdiDi>
    <tradeName>05018632288999</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Paul Murray plc</manufacturerName>
    <manufacturerSrn>GB-MF-000009853</manufacturerSrn>
    <authorisedRepresentativeName>Murrays Health and Beauty Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003274</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05010203</emdnCode>
    <emdnDescription>URINE COLLECTION, CONTAINERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA8385</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:51:56.785Z</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>
</eudamedExport>