Public EUDAMED Search

EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

22.09.2026 16:13

Sync status

Successful

Device

3537229

Actor

47754

Certificate

3383

Active filter:Manufacturer SRN:KR-MF-000045858

33 device results listed.

Page 1 / 2

PowerChek™ SARS-CoV-2, Influenza A&B Multiplex Real-time PCR Kit

PowerChek™ SARS-CoV-2, Influenza A&B Multiplex Real-time PCR Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
KogeneBiotech Co., Ltd.
Manufacturer SRN
KR-MF-000045858
UDI-DI
08800056369333
Basic UDI-DI
B-08800056369333
Reference
IR6903N
EMDN
W0105070304
EMDN description
INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country
Czechia
Authorised representative
Obelis s.a.
Last updated
10.07.2026 01:32
PowerChek™ SARS-CoV-2, Influenza A&B, RSV Multiplex Real-time PCR Kit II

PowerChek™ SARS-CoV-2, Influenza A&B, RSV Multiplex Real-time PCR Kit II

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
KogeneBiotech Co., Ltd.
Manufacturer SRN
KR-MF-000045858
UDI-DI
08800056369302
Basic UDI-DI
B-08800056369302
Reference
R6905Q
EMDN
W0105070304
EMDN description
INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country
Belgium
Authorised representative
Obelis s.a.
Last updated
10.07.2026 01:32
PowerChek™ SARS-CoV-2, Influenza A&B, RSV Multiplex Real-time PCR Kit II

PowerChek™ SARS-CoV-2, Influenza A&B, RSV Multiplex Real-time PCR Kit II

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
KogeneBiotech Co., Ltd.
Manufacturer SRN
KR-MF-000045858
UDI-DI
08800056369296
Basic UDI-DI
B-08800056369296
Reference
R6905N
EMDN
W0105070304
EMDN description
INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country
Czechia
Authorised representative
Obelis s.a.
Last updated
10.07.2026 01:32
PowerChek™ SARS-CoV-2, Influenza A&B Multiplex Real-time PCR Kit

PowerChek™ SARS-CoV-2, Influenza A&B Multiplex Real-time PCR Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
KogeneBiotech Co., Ltd.
Manufacturer SRN
KR-MF-000045858
UDI-DI
08800056369234
Basic UDI-DI
B-08800056369234
Reference
IR6903Q
EMDN
W0105070304
EMDN description
INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country
Czechia
Authorised representative
Obelis s.a.
Last updated
10.07.2026 01:32
PowerChek™ SARS-CoV-2 Advanced Real-time PCR Kit

PowerChek™ SARS-CoV-2 Advanced Real-time PCR Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
KogeneBiotech Co., Ltd.
Manufacturer SRN
KR-MF-000045858
UDI-DI
08800056369104
Basic UDI-DI
B-08800056369104
Reference
IR6906
EMDN
W0105041106
EMDN description
CORONAVIRUS - NA REAGENTS
First on market country
Czechia
Authorised representative
Obelis s.a.
Last updated
10.07.2026 01:32
PowerChek™ SARS-CoV-2, Influenza A&B, RSV Multiplex Real-time PCR Kit

PowerChek™ SARS-CoV-2, Influenza A&B, RSV Multiplex Real-time PCR Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
KogeneBiotech Co., Ltd.
Manufacturer SRN
KR-MF-000045858
UDI-DI
08800056369098
Basic UDI-DI
B-08800056369098
Reference
IR6904
EMDN
W0105070304
EMDN description
INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country
Czechia
Authorised representative
Obelis s.a.
Last updated
10.07.2026 01:32
PowerChek™ SARS-CoV-2 Real-time PCR Kit

PowerChek™ SARS-CoV-2 Real-time PCR Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
KogeneBiotech Co., Ltd.
Manufacturer SRN
KR-MF-000045858
UDI-DI
08800056369029
Basic UDI-DI
B-08800056369029
Reference
IR6902
EMDN
W0105041106
EMDN description
CORONAVIRUS - NA REAGENTS
First on market country
Czechia
Authorised representative
Obelis s.a.
Last updated
10.07.2026 01:32
PowerChek™ Coronavirus 229E / OC43 / NL63 / HKU1 Real-time PCR Kit Ver.1.0

PowerChek™ Coronavirus 229E / OC43 / NL63 / HKU1 Real-time PCR Kit Ver.1.0

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
KogeneBiotech Co., Ltd.
Manufacturer SRN
KR-MF-000045858
UDI-DI
08800056364031
Basic UDI-DI
B-08800056364031
Reference
R6410TA
EMDN
W0105041106
EMDN description
CORONAVIRUS - NA REAGENTS
First on market country
Czechia
Authorised representative
Obelis s.a.
Last updated
10.07.2026 01:32
PowerChek™ RSV A & B/HMV Real-time PCR Kit

PowerChek™ RSV A & B/HMV Real-time PCR Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
KogeneBiotech Co., Ltd.
Manufacturer SRN
KR-MF-000045858
UDI-DI
08800056363034
Basic UDI-DI
B-08800056363034
Reference
R6300T
EMDN
W0105070503
EMDN description
RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country
Czechia
Authorised representative
Obelis s.a.
Last updated
10.07.2026 01:32
PowerChek™ Parainfluenza Virus 1/2/3 Real-time PCR Kit

PowerChek™ Parainfluenza Virus 1/2/3 Real-time PCR Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
KogeneBiotech Co., Ltd.
Manufacturer SRN
KR-MF-000045858
UDI-DI
08800056362037
Basic UDI-DI
B-08800056362037
Reference
R6200T
EMDN
W0105040504
EMDN description
INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country
Czechia
Authorised representative
Obelis s.a.
Last updated
10.07.2026 01:32
PowerChek™ Adenovirus / Bocavirus Real-time PCR Kit

PowerChek™ Adenovirus / Bocavirus Real-time PCR Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
KogeneBiotech Co., Ltd.
Manufacturer SRN
KR-MF-000045858
UDI-DI
08800056361030
Basic UDI-DI
B-08800056361030
Reference
R6100T
EMDN
W0105070503
EMDN description
RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country
Czechia
Authorised representative
Obelis s.a.
Last updated
10.07.2026 01:32
PowerChek™ ZIKV / DENV / CHIKV Multiplex Real-time PCR Kit

PowerChek™ ZIKV / DENV / CHIKV Multiplex Real-time PCR Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
KogeneBiotech Co., Ltd.
Manufacturer SRN
KR-MF-000045858
UDI-DI
08800056355008
Basic UDI-DI
B-08800056355008
Reference
R5504
EMDN
W0105070506
EMDN description
TROPICAL FEVER - MULTIPLEX NA REAGENTS
First on market country
Czechia
Authorised representative
Obelis s.a.
Last updated
10.07.2026 01:32
PowerChek™ Measles virus Real-time PCR Kit Ver.1.0

PowerChek™ Measles virus Real-time PCR Kit Ver.1.0

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
KogeneBiotech Co., Ltd.
Manufacturer SRN
KR-MF-000045858
UDI-DI
08800056331026
Basic UDI-DI
B-08800056331026
Reference
R3130TA
EMDN
W0105040704
EMDN description
MEASLES - NA REAGENTS
First on market country
Czechia
Authorised representative
Obelis s.a.
Last updated
10.07.2026 01:32
PowerChek™ Influenza A&B, RSV Multiplex Real-time PCR Kit

PowerChek™ Influenza A&B, RSV Multiplex Real-time PCR Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
KogeneBiotech Co., Ltd.
Manufacturer SRN
KR-MF-000045858
UDI-DI
08800056336007
Basic UDI-DI
B-08800056336007
Reference
IR3600
EMDN
W0105070304
EMDN description
INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country
Czechia
Authorised representative
Obelis s.a.
Last updated
10.07.2026 01:32
PowerChek™ MeV / MeVA Multiplex Real-time PCR Kit

PowerChek™ MeV / MeVA Multiplex Real-time PCR Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
KogeneBiotech Co., Ltd.
Manufacturer SRN
KR-MF-000045858
UDI-DI
08800056331002
Basic UDI-DI
B-08800056331002
Reference
R3136TA
EMDN
W0105040704
EMDN description
MEASLES - NA REAGENTS
First on market country
Czechia
Authorised representative
Obelis s.a.
Last updated
10.07.2026 01:32
PowerChek™ Mumps Real-time PCR Kit Ver.1.1

PowerChek™ Mumps Real-time PCR Kit Ver.1.1

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
KogeneBiotech Co., Ltd.
Manufacturer SRN
KR-MF-000045858
UDI-DI
08800056331019
Basic UDI-DI
B-08800056331019
Reference
R3110TA
EMDN
W0105040804
EMDN description
MUMPS / PAROTITIS - NA REAGENTS
First on market country
Czechia
Authorised representative
Obelis s.a.
Last updated
10.07.2026 01:32
PowerChek™ Influenza B (Victoria & Yamagata) Real-time PCR Kit Ver.1.1

PowerChek™ Influenza B (Victoria & Yamagata) Real-time PCR Kit Ver.1.1

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
KogeneBiotech Co., Ltd.
Manufacturer SRN
KR-MF-000045858
UDI-DI
08800056330005
Basic UDI-DI
B-08800056330005
Reference
R3013TA
EMDN
W0105040504
EMDN description
INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country
Czechia
Authorised representative
Obelis s.a.
Last updated
10.07.2026 01:32
PowerChek™ STI Multiplex Real-time PCR Kit Ⅲ

PowerChek™ STI Multiplex Real-time PCR Kit Ⅲ

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
KogeneBiotech Co., Ltd.
Manufacturer SRN
KR-MF-000045858
UDI-DI
08800056319024
Basic UDI-DI
B-08800056319024
Reference
CQ19TTO0003Z
EMDN
W0105070501
EMDN description
STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country
Czechia
Authorised representative
Obelis s.a.
Last updated
10.07.2026 01:32
PowerChek™ STI Multiplex Real-time PCR KitⅡ

PowerChek™ STI Multiplex Real-time PCR KitⅡ

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
KogeneBiotech Co., Ltd.
Manufacturer SRN
KR-MF-000045858
UDI-DI
08800056319017
Basic UDI-DI
B-08800056319017
Reference
CQ19TTO0002Z
EMDN
W0105070501
EMDN description
STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country
Czechia
Authorised representative
Obelis s.a.
Last updated
10.07.2026 01:32
PowerChek™ 20 Bacterial Panel Kit

PowerChek™ 20 Bacterial Panel Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
KogeneBiotech Co., Ltd.
Manufacturer SRN
KR-MF-000045858
UDI-DI
08800056315002
Basic UDI-DI
B-08800056315002
Reference
R1501
EMDN
W0105070504
EMDN description
GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country
Czechia
Authorised representative
Obelis s.a.
Last updated
10.07.2026 01:32