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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 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

AFIAS Total βhCG

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133046975
Basic UDI-DI: 880613300509CE
Reference: SMFP-3
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
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

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

AFIAS Tn-I Plus

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133043080
Basic UDI-DI: 880613300524CA
Reference: SMFP-35
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Netherlands
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 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133041314
Basic UDI-DI: 880613300598D7
Reference: SMFP-108
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Cyprus
Authorised representative: Obelis s.a.
Last updated: 01.07.2026 05:38

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS Testosterone

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133040997
Basic UDI-DI: 880613300519CH
Reference: SMFP-29
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Netherlands
Authorised representative: Obelis s.a.
Last updated: 01.07.2026 05:38

Manufacturer products Authorised representative products Authorised representative actors View details