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<eudamedExport entity="devices">
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    <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>05061041770005</udiDi>
    <basicUdiDi>506104177CN4201NP</basicUdiDi>
    <tradeName>ClearNote</tradeName>
    <deviceName>ClearNote Health Specimen Collection Kit</deviceName>
    <manufacturerName>Roylance Scientific LTD</manufacturerName>
    <manufacturerSrn>UK-MF-000040266</manufacturerSrn>
    <authorisedRepresentativeName>Casus Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000037688</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050101010202</emdnCode>
    <emdnDescription>BLOOD COLLECTION, TUBES WITHOUT ADDITIVES OR SERUM SEPARATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CN4201</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:08:02.372Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060950150007</udiDi>
    <basicUdiDi>506095015EXB001YL</basicUdiDi>
    <tradeName>05060950150007</tradeName>
    <deviceName>12ml Exetainer® Breath Vials</deviceName>
    <manufacturerName>Labco Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000025515</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0503010101</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, GLASS TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>438B</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:57:56.348Z</lastUpdated>
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  <row>
    <udiDi>05060941800508</udiDi>
    <basicUdiDi>506094180BHTK86</basicUdiDi>
    <tradeName>Better2Know</tradeName>
    <deviceName>DNA, Blood and Urine Collection Kits</deviceName>
    <manufacturerName>Better2Know</manufacturerName>
    <manufacturerSrn>UK-MF-000044952</manufacturerSrn>
    <authorisedRepresentativeName>Patient Guard Europe UG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007523</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050101010102</emdnCode>
    <emdnDescription>BLOOD COLLECTION, CLOSED SYRINGES WITHOUT ADDITIVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BHTK0025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:57:38.728Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060757350907</udiDi>
    <basicUdiDi>506075735R4000Y6</basicUdiDi>
    <tradeName>05060757350907</tradeName>
    <deviceName>Retest Blood Kit (Gold &amp; Lavender)</deviceName>
    <manufacturerName>Concepta Diagnostics</manufacturerName>
    <manufacturerSrn>GB-PR-000033063</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W0501010201</emdnCode>
    <emdnDescription>CAPILLARY BLOOD COLLECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R4000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:53:36.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060757350891</udiDi>
    <basicUdiDi>506075735R3000XX</basicUdiDi>
    <tradeName>05060757350891</tradeName>
    <deviceName>Retest Blood Kit (Single Lavender)</deviceName>
    <manufacturerName>Concepta Diagnostics</manufacturerName>
    <manufacturerSrn>GB-PR-000033063</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W0501010201</emdnCode>
    <emdnDescription>CAPILLARY BLOOD COLLECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R3000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:53:34.663Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060757350884</udiDi>
    <basicUdiDi>506075735R2000XQ</basicUdiDi>
    <tradeName>05060757350884</tradeName>
    <deviceName>Retest Blood Kit (Single Gold)</deviceName>
    <manufacturerName>Concepta Diagnostics</manufacturerName>
    <manufacturerSrn>GB-PR-000033063</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W0501010201</emdnCode>
    <emdnDescription>CAPILLARY BLOOD COLLECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R2000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:53:33.874Z</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>05060757350846</udiDi>
    <basicUdiDi>506075735P5000XP</basicUdiDi>
    <tradeName>MyHealthChecked</tradeName>
    <deviceName>MyHealthChecked Phlebotomy Sample Collection Kit (butterfly needle)– Gold &amp; Lavender Tube (Single Test)</deviceName>
    <manufacturerName>Concepta Diagnostics</manufacturerName>
    <manufacturerSrn>GB-PR-000033063</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W0501010199</emdnCode>
    <emdnDescription>VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P5000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:53:29.847Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060757350860</udiDi>
    <basicUdiDi>506075735W3000ZN</basicUdiDi>
    <tradeName>05060757350860</tradeName>
    <deviceName>Boots 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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W0501010201</emdnCode>
    <emdnDescription>CAPILLARY BLOOD COLLECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W3000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:53:28.254Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060757350853</udiDi>
    <basicUdiDi>506075735W2000ZF</basicUdiDi>
    <tradeName>05060757350853</tradeName>
    <deviceName>Boots 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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W0501010201</emdnCode>
    <emdnDescription>CAPILLARY BLOOD COLLECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W2000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:53:27.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060757350839</udiDi>
    <basicUdiDi>506075735P4000XG</basicUdiDi>
    <tradeName>MyHealthChecked</tradeName>
    <deviceName>MyHealthChecked Phlebotomy Sample Collection Kit (butterfly needle) – Gold Tube (Single Test)</deviceName>
    <manufacturerName>Concepta Diagnostics</manufacturerName>
    <manufacturerSrn>GB-PR-000033063</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W0501010199</emdnCode>
    <emdnDescription>VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P4000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:53:11.395Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060757350822</udiDi>
    <basicUdiDi>506075735P3000X9</basicUdiDi>
    <tradeName>05060757350822</tradeName>
    <deviceName>MyHealthChecked Phlebotomy Sample Collection Kit – Gold &amp; Lavender Tube</deviceName>
    <manufacturerName>Concepta Diagnostics</manufacturerName>
    <manufacturerSrn>GB-PR-000033063</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W0501010199</emdnCode>
    <emdnDescription>VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P3000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:53:10.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060757350815</udiDi>
    <basicUdiDi>506075735P2000X2</basicUdiDi>
    <tradeName>05060757350815</tradeName>
    <deviceName>The MyHealthChecked Phlebotomy Blood Sample Collection Kit – Gold Tube</deviceName>
    <manufacturerName>Concepta Diagnostics</manufacturerName>
    <manufacturerSrn>GB-PR-000033063</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W0501010199</emdnCode>
    <emdnDescription>VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:53:09.790Z</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>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>05060246860436</udiDi>
    <basicUdiDi>506024686BB0123</basicUdiDi>
    <tradeName>05060246860436</tradeName>
    <deviceName>Gastrocheck Bag</deviceName>
    <manufacturerName>Bedfont Scientific Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000010889</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W05020105</emdnCode>
    <emdnDescription>SAMPLES TRANSPORT, BAGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GASTROCHECK BAG, GASTROCHECK-BAG-XL</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:35:59.812Z</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>
</eudamedExport>