<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08595223921918</udiDi>
    <basicUdiDi>B-08595223921918</basicUdiDi>
    <tradeName>gb GENETIC LACTO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GENERI BIOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000018857</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010299</emdnCode>
    <emdnDescription>POLYGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3219-025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:52:28.445Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595223920621</udiDi>
    <basicUdiDi>85952239000003WY</basicUdiDi>
    <tradeName>gb GENETIC APOE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GENERI BIOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000018857</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3206-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:47:38.069Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595223920812</udiDi>
    <basicUdiDi>85952239000005X4</basicUdiDi>
    <tradeName>gb GENETIC HFE</tradeName>
    <deviceName>gb GENETIC HFE</deviceName>
    <manufacturerName>GENERI BIOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000018857</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010105</emdnCode>
    <emdnDescription>HAEMOCHROMATOSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3208-025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:57:46.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595223925732</udiDi>
    <basicUdiDi>85952239000006X6</basicUdiDi>
    <tradeName>gb GENETIC HLA-B*27</tradeName>
    <deviceName>gb GENETIC HLA-B*27</deviceName>
    <manufacturerName>GENERI BIOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000018857</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3257-100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:57:24.453Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595223925718</udiDi>
    <basicUdiDi>85952239000006X6</basicUdiDi>
    <tradeName>gb GENETIC HLA-B*27</tradeName>
    <deviceName>gb GENETIC HLA-B*27</deviceName>
    <manufacturerName>GENERI BIOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000018857</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3257-025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:57:23.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595223925527</udiDi>
    <basicUdiDi>85952239000020WY</basicUdiDi>
    <tradeName>gb PHARM DPYD</tradeName>
    <deviceName>gb PHARM DPYD</deviceName>
    <manufacturerName>GENERI BIOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000018857</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3255-050</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:57:22.050Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595223925510</udiDi>
    <basicUdiDi>85952239000020WY</basicUdiDi>
    <tradeName>gb PHARM DPYD</tradeName>
    <deviceName>gb PHARM DPYD</deviceName>
    <manufacturerName>GENERI BIOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000018857</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3255-025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:57:16.061Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595223925428</udiDi>
    <basicUdiDi>85952239000016X9</basicUdiDi>
    <tradeName>gb PHARM CYP2C19</tradeName>
    <deviceName>gb PHARM CYP2C19</deviceName>
    <manufacturerName>GENERI BIOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000018857</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106030104</emdnCode>
    <emdnDescription>CYP2C19</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3254-050</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:57:14.848Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595223925411</udiDi>
    <basicUdiDi>85952239000016X9</basicUdiDi>
    <tradeName>gb PHARM CYP2C19</tradeName>
    <deviceName>gb PHARM CYP2C19</deviceName>
    <manufacturerName>GENERI BIOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000018857</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106030104</emdnCode>
    <emdnDescription>CYP2C19</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3254-025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:57:13.650Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595223925022</udiDi>
    <basicUdiDi>85952239000019XF</basicUdiDi>
    <tradeName>gb PHARM Warfarin</tradeName>
    <deviceName>gb PHARM Warfarin</deviceName>
    <manufacturerName>GENERI BIOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000018857</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3250-050</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:57:12.443Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595223925015</udiDi>
    <basicUdiDi>85952239000019XF</basicUdiDi>
    <tradeName>gb PHARM Warfarin</tradeName>
    <deviceName>gb PHARM Warfarin</deviceName>
    <manufacturerName>GENERI BIOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000018857</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3250-025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:57:06.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595223921925</udiDi>
    <basicUdiDi>85952239000007X8</basicUdiDi>
    <tradeName>gb GENETIC LACTO</tradeName>
    <deviceName>gb GENETIC LACTO</deviceName>
    <manufacturerName>GENERI BIOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000018857</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010299</emdnCode>
    <emdnDescription>POLYGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3219-050</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:57:05.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595223921727</udiDi>
    <basicUdiDi>85952239000018XD</basicUdiDi>
    <tradeName>gb PHARM TPMT</tradeName>
    <deviceName>gb PHARM TPMT</deviceName>
    <manufacturerName>GENERI BIOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000018857</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3217-050</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:57:04.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595223921710</udiDi>
    <basicUdiDi>85952239000018XD</basicUdiDi>
    <tradeName>gb PHARM TPMT</tradeName>
    <deviceName>gb PHARM TPMT</deviceName>
    <manufacturerName>GENERI BIOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000018857</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3217-025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:57:02.848Z</lastUpdated>
  </row>
</eudamedExport>