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100 device results listed.

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ichroma™ M2 System check cartridge

IVD Class AIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133001578
Basic UDI-DI: 880613300157C5
Reference: FPCC170
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

5 μL Capillary tube

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133080696
Basic UDI-DI: 880613308069DX
Reference: CFPO-32
EMDN: W0501010203
EMDN description: BLOOD COLLECTION, CAPILLARY TUBES
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 05.07.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Boditech sphingotest® penKid® Calibrator

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133050071
Basic UDI-DI: 880613307078DR
Reference: CFPO-403
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

Boditech sphingotest® penKid® Control

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133050064
Basic UDI-DI: 880613306119D7
Reference: CFPO-402
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Netherlands
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:39

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: 08806133049945
Basic UDI-DI: 880613308054DJ
Reference: CFPO-206
EMDN: W050101010201
EMDN description: BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR
First on market country: Slovakia
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

Boditech Free PSA Calibrator

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133048528
Basic UDI-DI: 880613307141D7
Reference: CFPO-409
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Cyprus
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

Boditech Free PSA Control

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133048511
Basic UDI-DI: 880613306142D2
Reference: CFPO-406
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

Boditech PSA Calibrator

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133048504
Basic UDI-DI: 880613307011CR
Reference: CFPO-277
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Greece
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ IGRA-TB 25

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: 08806133045299
Basic UDI-DI: 880613300138BZ
Reference: CFPC-86-1
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Slovakia
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ PCT

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133044469
Basic UDI-DI: 88061330BD09JB
Reference: CFPC-23-1
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS PCT Plus G

IVD Class CNot specifiedOn the marketSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133044414
Basic UDI-DI: 880613300612C8
Reference: SMFP-112
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ AFP Neo

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133044216
Basic UDI-DI: 880613300123BL
Reference: CFPC-156
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Greece
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ PCT Plus G

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133044377
Basic UDI-DI: 880613300128BW
Reference: CFPC-136
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Lithuania
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ CEA Neo

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133044056
Basic UDI-DI: 880613300124BN
Reference: CFPC-158
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
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™ iFOB Neo

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133044018
Basic UDI-DI: 880613300038BU
Reference: CFPC-15-1
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ Cyfra21-1

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133043929
Basic UDI-DI: 880613300131BK
Reference: CFPC-140
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ CA19-9

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133043837
Basic UDI-DI: 880613300130BH
Reference: CFPC-139
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
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™ Free PSA

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133043745
Basic UDI-DI: 880613303018CB
Reference: CFPC-178
EMDN: W0102030114
EMDN description: FREE PROSTATIC SPECIFIC ANTIGEN
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™ PSA Neo

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133043585
Basic UDI-DI: 880613300133BP
Reference: CFPC-157
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
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™ 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