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    <basicUdiDi>150995905IM32515P</basicUdiDi>
    <tradeName>Albumin RIA KIT</tradeName>
    <deviceName>Albumin RIA KIT</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060199</emdnCode>
    <emdnDescription>DIABETES ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM3251</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:55:09.038Z</lastUpdated>
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    <udiDi>15099590218768</udiDi>
    <basicUdiDi>150995905IM32235J</basicUdiDi>
    <tradeName>Anti-hTg IRMA KIT</tradeName>
    <deviceName>Anti-hTg IRMA KIT</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100303</emdnCode>
    <emdnDescription>THYROGLOBULIN AUTOANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM3223</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:55:07.367Z</lastUpdated>
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    <udiDi>15099590218744</udiDi>
    <basicUdiDi>150995905IM321059</basicUdiDi>
    <tradeName>Insulin(e) IRMA KIT</tradeName>
    <deviceName>Insulin(e) IRMA KIT</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Im3210</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:55:04.969Z</lastUpdated>
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    <udiDi>15099590218690</udiDi>
    <basicUdiDi>150995905CA19-9IRMARN</basicUdiDi>
    <tradeName>IRMA CA 19-9 antigen</tradeName>
    <deviceName>IRMA CA 19-9 antigen</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM3151, B64313</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:55:03.362Z</lastUpdated>
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    <udiDi>15099590217785</udiDi>
    <basicUdiDi>150995905IM256264</basicUdiDi>
    <tradeName>EIA Histamine</tradeName>
    <deviceName>EIA Histamine</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020209</emdnCode>
    <emdnDescription>HISTAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM2562</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:54:52.161Z</lastUpdated>
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    <udiDi>15099590217730</udiDi>
    <basicUdiDi>150995905IM25205L</basicUdiDi>
    <tradeName>PSA free IRMA KIT</tradeName>
    <deviceName>PSA free IRMA KIT</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030114</emdnCode>
    <emdnDescription>FREE PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM2520</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:54:36.901Z</lastUpdated>
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  <row>
    <udiDi>15099590217525</udiDi>
    <basicUdiDi>150995905IM24596A</basicUdiDi>
    <tradeName>Free β-hCG IRMA KIT</tradeName>
    <deviceName>Free β-hCG IRMA KIT</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050213</emdnCode>
    <emdnDescription>FREE BETA HCG (PRENATAL SCREENING)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM2459</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:54:20.093Z</lastUpdated>
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    <udiDi>15099590217402</udiDi>
    <basicUdiDi>150995905CA15-3IRMAMG</basicUdiDi>
    <tradeName>IRMA MUC-1 gene associated antigen (CA 15-3)</tradeName>
    <deviceName>IRMA MUC-1 gene associated antigen (CA 15-3)</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM2397</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:54:18.498Z</lastUpdated>
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    <udiDi>15099590217044</udiDi>
    <basicUdiDi>150995905IM22355J</basicUdiDi>
    <tradeName>hCG screening RIA KIT</tradeName>
    <deviceName>hCG screening RIA KIT</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050205</emdnCode>
    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM2235</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:54:17.696Z</lastUpdated>
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    <udiDi>15099590217020</udiDi>
    <basicUdiDi>150995905CA125IRMAFQ</basicUdiDi>
    <tradeName>IRMA CA 125 antigen</tradeName>
    <deviceName>IRMA CA 125 antigen</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030106</emdnCode>
    <emdnDescription>CANCER ANTIGEN 125</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM2233</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:54:16.091Z</lastUpdated>
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    <udiDi>15099590216887</udiDi>
    <basicUdiDi>150995905CEAIRMAHL</basicUdiDi>
    <tradeName>CEA IRMA KIT</tradeName>
    <deviceName>CEA IRMA KIT</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM2204</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:54:12.096Z</lastUpdated>
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    <udiDi>15099590216764</udiDi>
    <basicUdiDi>150995905FSHIRMATA</basicUdiDi>
    <tradeName>FSH IRMA KIT</tradeName>
    <deviceName>FSH IRMA KIT</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM2125</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:54:11.326Z</lastUpdated>
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    <udiDi>15099590216733</udiDi>
    <basicUdiDi>150995905PRLIRMAZK</basicUdiDi>
    <tradeName>Prolactin IRMA KIT</tradeName>
    <deviceName>Prolactin IRMA KIT</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM2121</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:54:09.690Z</lastUpdated>
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    <udiDi>15099590216429</udiDi>
    <basicUdiDi>150995905ACTHIRMAYL</basicUdiDi>
    <tradeName>IRMA ACTH</tradeName>
    <deviceName>IRMA ACTH</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060401</emdnCode>
    <emdnDescription>ADRENOCORTIOTROPIC HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM2030</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:54:07.296Z</lastUpdated>
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    <udiDi>15099590216207</udiDi>
    <basicUdiDi>150995905IM19506A</basicUdiDi>
    <tradeName>PSA total IRMA KIT</tradeName>
    <deviceName>PSA total IRMA KIT</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM1950</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:54:05.679Z</lastUpdated>
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    <udiDi>15099590216191</udiDi>
    <basicUdiDi>150995905IM19486P</basicUdiDi>
    <tradeName>THYMIDINE KINASE REA KIT</tradeName>
    <deviceName>THYMIDINE KINASE REA KIT</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039008</emdnCode>
    <emdnDescription>THYMIDINE KINASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM1948</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:54:04.886Z</lastUpdated>
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    <udiDi>15099590215842</udiDi>
    <basicUdiDi>150995905IM184164</basicUdiDi>
    <tradeName>Cortisol RIA KIT</tradeName>
    <deviceName>CORTISOL RIA KIT</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060203</emdnCode>
    <emdnDescription>CORTISOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM1841</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:54:00.879Z</lastUpdated>
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    <udiDi>15099590215385</udiDi>
    <basicUdiDi>150995905IM166466</basicUdiDi>
    <tradeName>RIA Aldosterone</tradeName>
    <deviceName>RIA Aldosterone</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060201</emdnCode>
    <emdnDescription>ALDOSTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM1664</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:53:54.478Z</lastUpdated>
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    <udiDi>15099590215378</udiDi>
    <basicUdiDi>150995905IM16596D</basicUdiDi>
    <tradeName>RIA Histamine</tradeName>
    <deviceName>RIA Histamine</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020209</emdnCode>
    <emdnDescription>HISTAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM1659</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:53:49.778Z</lastUpdated>
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    <udiDi>15099590214999</udiDi>
    <basicUdiDi>150995905FT3RIAEF</basicUdiDi>
    <tradeName>RIA FT3</tradeName>
    <deviceName>RIA FT3</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020401</emdnCode>
    <emdnDescription>FREE TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM1579, IM3320</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:53:36.021Z</lastUpdated>
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