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    <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></emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCK10665</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:42:32.446Z</lastUpdated>
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    <udiDi>05055273219814</udiDi>
    <basicUdiDi>50552732BPTHSMT176XP</basicUdiDi>
    <tradeName>PARATHYROID HORMONE CONTROL - LEVEL 1 (PTH CONTROL 1)</tradeName>
    <deviceName>PTH CONTROL</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PTH10608</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:42:31.629Z</lastUpdated>
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    <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></emdnCode>
    <emdnDescription>VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCK10694</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:42:30.832Z</lastUpdated>
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    <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></emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCK10693</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:42:30.133Z</lastUpdated>
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    <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></emdnCode>
    <emdnDescription>CAPILLARY BLOOD COLLECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCK10677</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:42:15.559Z</lastUpdated>
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    <udiDi>05055273219609</udiDi>
    <basicUdiDi>50552732BSHBGAK163CA</basicUdiDi>
    <tradeName>Evidence MultiSTAT SHBG</tradeName>
    <deviceName>Evidence MultiSTAT SHBG</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SEX HORMONE BINDING GLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV4514</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:42:14.767Z</lastUpdated>
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  <row>
    <udiDi>05055273219593</udiDi>
    <basicUdiDi>50552732BSHBGCK164D2</basicUdiDi>
    <tradeName>Evidence MultiSTAT SHBG Control</tradeName>
    <deviceName>Evidence MultiSTAT SHBG Control</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV4533</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:42:13.987Z</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></emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCK10654</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:42:12.363Z</lastUpdated>
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    <udiDi>05055273219029</udiDi>
    <basicUdiDi>50552732BAVB12C173QK</basicUdiDi>
    <tradeName>ACTIVE VITAMIN B12 CONTROL LEVEL 1 (Active Vitamin B12 CONTROL 1)</tradeName>
    <deviceName>ACTIVE VITAMIN B12 CONTROL</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VB10524</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:42:11.562Z</lastUpdated>
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  <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></emdnCode>
    <emdnDescription>VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CZM10594</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:42:10.765Z</lastUpdated>
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    <udiDi>05055273218848</udiDi>
    <basicUdiDi>50552732BAGRCON157B9</basicUdiDi>
    <tradeName>ALDOLASE AND GLUTATHIONE REDUCTASE LEVEL 2 CONTROL (ALS &amp; GLUT RED CONTROL 2)</tradeName>
    <deviceName>ALDOLASE AND GLUTATHIONE REDUCTASE CONTROL</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AGR10572</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:42:09.959Z</lastUpdated>
  </row>
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    <udiDi>05055273218831</udiDi>
    <basicUdiDi>50552732BAGRCAL1565X</basicUdiDi>
    <tradeName>ALDOLASE AND GLUTATHIONE REDUCTASE CALIBRATOR (ALS &amp; GLUT RED CAL)</tradeName>
    <deviceName>ALDOLASE AND GLUTATHIONE REDUCTASE CALIBRATOR (ALS &amp; GLUT RED CAL)</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AGR10571</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:42:09.167Z</lastUpdated>
  </row>
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    <udiDi>05055273217933</udiDi>
    <basicUdiDi>50552732BHBPOCT140DS</basicUdiDi>
    <tradeName>SEROLOGY HBeAg POSITIVE CONTROL (HBeAg CONTROL +)</tradeName>
    <deviceName>SEROLOGY HBeAg POSITIVE CONTROL</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CONTROLS - INF. IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR10459</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:42:08.355Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273217926</udiDi>
    <basicUdiDi>50552732BLBCNL30345F</basicUdiDi>
    <tradeName>Custom Bilirubin Control - Level 3 (CUSTOM BILIRUBIN CONTROL 3)</tradeName>
    <deviceName>Custom Bilirubin Control - Level 3 (CUSTOM BILIRUBIN CONTROL 3)</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BILIRUBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BR10391</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:42:07.561Z</lastUpdated>
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    <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></emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV3879</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:42:06.785Z</lastUpdated>
  </row>
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    <udiDi>05055273217513</udiDi>
    <basicUdiDi>50552732BLIC123180MW</basicUdiDi>
    <tradeName>CUSTOM LIQUID IMMUNOASSAY CONTROL - LEVEL 1</tradeName>
    <deviceName>CUSTOM LIQUID IMMUNOASSAY CONTROL</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LIA3148</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:42:05.976Z</lastUpdated>
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    <udiDi>05055273217315</udiDi>
    <basicUdiDi>50552732BLTDCON177KM</basicUdiDi>
    <tradeName>CUSTOM LIQUID THERAPEUTIC DRUG CONTROL - LEVEL 1</tradeName>
    <deviceName>CUSTOM LIQUID THERAPEUTIC DRUG CONTROL</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HD3145</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:42:05.162Z</lastUpdated>
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    <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></emdnCode>
    <emdnDescription>CAPILLARY BLOOD COLLECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV4460</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:42:04.362Z</lastUpdated>
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    <udiDi>05055273217117</udiDi>
    <basicUdiDi>50552732BCRDCON001AS</basicUdiDi>
    <tradeName>CARDIAC CONTROL - ULTRA LOW (CRD CONTROL Ultra Low)</tradeName>
    <deviceName>CARDIAC CONTROL</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CARDIAC MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CQ10453</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:42:03.562Z</lastUpdated>
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    <udiDi>05055273217100</udiDi>
    <basicUdiDi>50552732BAGPOCO125AR</basicUdiDi>
    <tradeName>SEROLOGY  HIV-1 P24Ag POSITIVE CONTROL (HIV-1 P24Ag  CONTROL +)</tradeName>
    <deviceName>SEROLOGY  HIV-1 P24Ag POSITIVE CONTROL</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CONTROLS - INF. IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR10458</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:42:02.767Z</lastUpdated>
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