Public EUDAMED Search

EUDAMED Device Search

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

TR EN

Last updated

22.09.2026 08:45

Sync status

Successful

Device

3535217

Actor

47706

Certificate

3367

Filters

Show filters

Active filter:Manufacturer SRN:KR-MF-000011028

101 device results listed.

Page 5 / 6

CSV XML

ichroma™ hsCRP

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133043455
Basic UDI-DI: 880613300063BT
Reference: CFPC-6
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Bulgaria
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ BNP

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133043363
Basic UDI-DI: 880613300072BU
Reference: CFPC-121
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Greece
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ Tn-I Neo

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133042977
Basic UDI-DI: 880613300129BY
Reference: CFPC-150
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Cyprus
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ 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: 08806133042311
Basic UDI-DI: 880613300125BQ
Reference: CFPC-152
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Cyprus
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS-1H

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010600
Basic UDI-DI: 880613301060BU
Reference: FPRR054
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

CBChroma™

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010587
Basic UDI-DI: 880613301058C9
Reference: FPRR060
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

Urochroma™

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010556
Basic UDI-DI: 880613301055C3
Reference: FPRR062
EMDN: W020101020101
EMDN description: URINE STRIP READERS
First on market country: Portugal
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

IsoAmplar

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010471
Basic UDI-DI: 880613301047C4
Reference: FPRR043
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ II

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010044
Basic UDI-DI: 880613301004BJ
Reference: FPRR021
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ IGRA-TB for 8

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133048986
Basic UDI-DI: 880613300138BZ
Reference: CFPC-86-2
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ IGRA-TB Tube

IVD Class AIVDR 2017/746On the marketProfessional testingSingle useSterile

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133050088
Basic UDI-DI: 880613308054DJ
Reference: CFPO-206-24
EMDN: W050101010201
EMDN description: BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS Troponin T

IVD Class CIVDR 2017/746Not intended for EU marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133050927
Basic UDI-DI: 880613300573CP
Reference: SMFP-95-1
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 01.07.2026 05:38

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS Vitamin D Neo

IVD Class CIVDR 2017/746Not intended for EU marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133050828
Basic UDI-DI: 880613300598D7
Reference: SMFP-108-3
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 01.07.2026 05:38

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS sphingotest® penKid®

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133050750
Basic UDI-DI: 880613300653CN
Reference: SMFP-156-1
EMDN: W01021299
EMDN description: ORGAN FUNCTION ASSAYS - OTHER
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 01.07.2026 05:38

Manufacturer products Authorised representative products Authorised representative actors View details

Boditech iFOB Neo Calibrator

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133048979
Basic UDI-DI: 880613307142D9
Reference: CFPO-379
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 01.07.2026 05:38

Manufacturer products Authorised representative products Authorised representative actors View details

Boditech iFOB Neo Control

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133048962
Basic UDI-DI: 880613306006CR
Reference: CFPO-14
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 01.07.2026 05:38

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ IGRA-TB

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133045251
Basic UDI-DI: 880613300138BZ
Reference: CFPC-86
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Slovakia
Authorised representative: Obelis s.a.
Last updated: 01.07.2026 05:38

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS sphingotest® penKid®

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133045206
Basic UDI-DI: 880613300653CN
Reference: SMFP-156
EMDN: W01021299
EMDN description: ORGAN FUNCTION ASSAYS - OTHER
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 01.07.2026 05:38

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS iFOB Neo

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133045152
Basic UDI-DI: 880613300659D2
Reference: SMFP-148
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 01.07.2026 05:38

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS Troponin T

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133043172
Basic UDI-DI: 880613300573CP
Reference: SMFP-95
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Greece
Authorised representative: Obelis s.a.
Last updated: 01.07.2026 05:38

Manufacturer products Authorised representative products Authorised representative actors View details