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EUDAMED Device Search

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

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Active filter:Manufacturer SRN:KR-MF-000011028

92 device results listed.

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AFIAS NT-proBNP/ST2

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133042830
Basic UDI-DI: 880613300626CK
Reference: SMFP-85
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ NT-proBNP/ST2

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133042793
Basic UDI-DI: 880613300029BT
Reference: CFPC-163
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS CK-MB Neo

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133042380
Basic UDI-DI: 880613300608CH
Reference: SMFP-128
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS Dengue IgG/IgM

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133042090
Basic UDI-DI: 880613300548CQ
Reference: SMFP-41
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS NORO

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133041796
Basic UDI-DI: 880613300530C5
Reference: SMFP-26
EMDN: W0105040616
EMDN description: NOROVIRUS
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS IL-6

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133041482
Basic UDI-DI: 880613300565CQ
Reference: SMFP-74
EMDN: W01030609
EMDN description: INTERLEUKIN 6 (IL-6)
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS Cortisol

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133041154
Basic UDI-DI: 880613300520C2
Reference: SMFP-22
EMDN: W0102060203
EMDN description: CORTISOL
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ System check cartridge

IVD Class AIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133030172
Basic UDI-DI: 880613303017C9
Reference: FPCC152
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ Trio

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010617
Basic UDI-DI: 880613301061BW
Reference: FPRR056
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

Chemichroma™

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010532
Basic UDI-DI: 880613301053BX
Reference: FPRR058
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

Alchemis

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010488
Basic UDI-DI: 880613301048C6
Reference: FPRR048
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

ez-Track¹

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010426
Basic UDI-DI: 880613301042BS
Reference: FPRR019-15
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS-3

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010341
Basic UDI-DI: 880613301034BT
Reference: FPRR040
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Romania
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS-10

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010310
Basic UDI-DI: 880613301031BM
Reference: FPRR038
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™-50

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010266
Basic UDI-DI: 880613301026BU
Reference: FPRR022
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™-50 PLUS

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010334
Basic UDI-DI: 880613301033BR
Reference: FPRR036
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

EZ POC Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010259
Basic UDI-DI: 880613301025BS
Reference: FPRR034
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

QDx Instacheck™-II

IVD Class AIVDR 2017/746Not intended for EU marketInstrumentProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010204
Basic UDI-DI: 880613301020BG
Reference: FPRR039
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ M3

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010129
Basic UDI-DI: 880613301012BH
Reference: FPRR035
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Sweden
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ M2

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010112
Basic UDI-DI: 880613301011BF
Reference: FPRR031
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details