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    <udiDi>05056013025801</udiDi>
    <basicUdiDi>505601300ULTCEIDCONTKN</basicUdiDi>
    <tradeName>Immunotyping Control</tradeName>
    <deviceName>Immunotyping Control</deviceName>
    <manufacturerName>Helena Biosciences Europe</manufacturerName>
    <manufacturerSrn>GB-MF-000028365</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V150</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:22:26.352Z</lastUpdated>
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  <row>
    <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>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PTH10608</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:13:52.834Z</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>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV4533</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:13:47.253Z</lastUpdated>
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    <udiDi>05055273219586</udiDi>
    <basicUdiDi>50552732BTESCON162Q2</basicUdiDi>
    <tradeName>Evidence MultiSTAT Testosterone Control</tradeName>
    <deviceName>Evidence MultiSTAT Testosterone 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>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV4532</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:13:46.449Z</lastUpdated>
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    <udiDi>05055273219098</udiDi>
    <basicUdiDi>50552732BSUBOMK154TC</basicUdiDi>
    <tradeName>SERUM BONE MARKER LEVEL 1 CONTROL (SERUM BONE MARKER CONTROL 1)</tradeName>
    <deviceName>SERUM BONE MARKER 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>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SBM10574</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:13:40.853Z</lastUpdated>
  </row>
  <row>
    <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>W0102152006</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VB10524</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:13:40.047Z</lastUpdated>
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  <row>
    <udiDi>05055273218992</udiDi>
    <basicUdiDi>50552732CPREECL063JH</basicUdiDi>
    <tradeName>PRE-ECLAMPSIA CONTROL LEVEL 3 (Pre-eclampsia CONTROL 3)</tradeName>
    <deviceName>PRE-ECLAMPSIA CONTROL</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021521</emdnCode>
    <emdnDescription>MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PE10529</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:13:36.048Z</lastUpdated>
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  <row>
    <udiDi>05055273218787</udiDi>
    <basicUdiDi>50552732CULOPSA062XC</basicUdiDi>
    <tradeName>Ultra-Low PSA Control (UL PSA Control)</tradeName>
    <deviceName>Ultra-Low PSA Control (UL PSA Control)</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TU10523</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:13:30.324Z</lastUpdated>
  </row>
  <row>
    <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>W01021521</emdnCode>
    <emdnDescription>MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LIA3148</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:13:05.796Z</lastUpdated>
  </row>
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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>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HD3145</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:13:04.991Z</lastUpdated>
  </row>
  <row>
    <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>W0102152004</emdnCode>
    <emdnDescription>CARDIAC MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CQ10453</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:13:00.185Z</lastUpdated>
  </row>
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    <udiDi>05055273216615</udiDi>
    <basicUdiDi>50552732BLSPC1218199</basicUdiDi>
    <tradeName>CUSTOM LIQUID SPECIFIC PROTEIN CONTROL - LEVEL 1</tradeName>
    <deviceName>CUSTOM LIQUID SPECIFIC PROTEIN 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>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS3151</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:12:52.980Z</lastUpdated>
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    <udiDi>05055273215557</udiDi>
    <basicUdiDi>50552732BSTFCAL104KM</basicUdiDi>
    <tradeName>SOLUBLE TRANSFERRIN RECEPTORS CALIBRATOR SERIES (STFR CAL)</tradeName>
    <deviceName>SOLUBLE TRANSFERRIN RECEPTORS CALIBRATOR SERIES</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>W0102152206</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TF10161</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:12:45.771Z</lastUpdated>
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    <udiDi>05055273215328</udiDi>
    <basicUdiDi>50552732BPHCLLC090EN</basicUdiDi>
    <tradeName>PARATHYROID HORMONE CONTROL - LEVEL 1 (PTH CONTROL 1)</tradeName>
    <deviceName>PARATHYROID HORMONE 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>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PTH10110</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:12:44.982Z</lastUpdated>
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    <udiDi>05055273209105</udiDi>
    <basicUdiDi>50552732BAPOCON016EE</basicUdiDi>
    <tradeName>APOLIPOPROTEIN CONTROL - LEVEL 1  (APO CONTROL 1)</tradeName>
    <deviceName>APOLIPOPROTEIN 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>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LE5016</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:11:55.259Z</lastUpdated>
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    <udiDi>05055273207873</udiDi>
    <basicUdiDi>50552732BETHCON051FZ</basicUdiDi>
    <tradeName>ETHANOL CALIBRATOR AND CONTROL SET (EtOH CAL/ CONTROL)</tradeName>
    <deviceName>ETHANOL CALIBRATOR AND CONTROL SET</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>W0102152209</emdnCode>
    <emdnDescription>DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DA2703</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:11:52.875Z</lastUpdated>
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    <udiDi>05055273204445</udiDi>
    <basicUdiDi>50552732BLIPCON082K4</basicUdiDi>
    <tradeName>LIPOPROTEIN (a) CONTROL (Lp (a) CONTROL 3)</tradeName>
    <deviceName>LIPOPROTEIN (a) 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>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LP3406</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:11:26.429Z</lastUpdated>
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    <udiDi>05055273204438</udiDi>
    <basicUdiDi>50552732BLCALSS081DM</basicUdiDi>
    <tradeName>LIPOPROTEIN (a) CALIBRATOR SERIES (Lp(a) CAL SET)</tradeName>
    <deviceName>LIPOPROTEIN (a) CALIBRATOR SERIES</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>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LP3404</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:11:25.640Z</lastUpdated>
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    <udiDi>05055273204414</udiDi>
    <basicUdiDi>50552732BAPOCAL01594</basicUdiDi>
    <tradeName>APOLIPOPROTEIN CALIBRATOR (APO CAL)</tradeName>
    <deviceName>APOLIPOPROTEIN CALIBRATOR</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>W0102152203</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LP3023</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:11:21.624Z</lastUpdated>
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    <udiDi>05055273204056</udiDi>
    <basicUdiDi>50552732BILPCAL107D7</basicUdiDi>
    <tradeName>IMMUNOGLOBULIN LIQUID PROTEIN CALIBRATOR (IG CAL)</tradeName>
    <deviceName>IMMUNOGLOBULIN LIQUID PROTEIN CALIBRATOR (IG 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>W0102152203</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IT3861</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:11:20.030Z</lastUpdated>
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