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Active filter:Manufacturer SRN:KR-MF-000011028

96 device results listed.

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Boditech PSA Control

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133048498
Basic UDI-DI: 880613306069DH
Reference: CFPO-250
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Bulgaria
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:00

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS Total βhCG

IVD Class BIVDR 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: 01.08.2026 00:00

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ Total IgE

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133045473
Basic UDI-DI: 880613300117BR
Reference: CFPC-91
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Bulgaria
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:00

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS Microalbumin

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133045374
Basic UDI-DI: 880613300516CB
Reference: SMFP-30
EMDN: W0102010309
EMDN description: ALBUMIN (IC) INCL. UALBUMIN
First on market country: Greece
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:00

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ Dengue NS1 Ag

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133042212
Basic UDI-DI: 880613300028BR
Reference: CFPC-62
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:00

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ichroma™ Dengue IgG/IgM

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133042137
Basic UDI-DI: 880613300027BP
Reference: CFPC-60
EMDN: W0105040611
EMDN description: DENGUE VIRUS
First on market country: Hungary
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:00

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS Dengue IgG/IgM

IVD Class BIVDR 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: 01.08.2026 00:00

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS NORO

IVD Class BIVDR 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: 01.08.2026 00:00

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AFIAS IL-6

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional 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: 01.08.2026 00:00

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS Vitamin D Neo

IVD Class BIVDR 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: 01.08.2026 00:00

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS Cortisol

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional 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: 01.08.2026 00:00

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AFIAS Testosterone

IVD Class BIVDR 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: 01.08.2026 00:00

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QDx Instacheck™-II

IVD Class AIVDR 2017/746On the 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: Poland
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:00

Manufacturer products Authorised representative products Authorised representative actors View details

Boditech Estradiol Control

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133050583
Basic UDI-DI: 880613305058D5
Reference: CFPO-434
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 07:00

Manufacturer products Authorised representative products Authorised representative actors View details

Boditech Estradiol Calibrator

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133050590
Basic UDI-DI: 880613305059D7
Reference: CFPO-435
EMDN: W0102152202
EMDN description: HORMONE STANDARDS AND CALIBRATORS
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 28.07.2026 01:23

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ Estradiol

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133050569
Basic UDI-DI: 880613305056CZ
Reference: CFPC-190
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 28.07.2026 01:23

Manufacturer products Authorised representative products Authorised representative actors View details

AFIAS Estradiol

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133050491
Basic UDI-DI: 880613305049D4
Reference: SMFP-184
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 27.07.2026 06:42

Manufacturer products Authorised representative products Authorised representative actors View details

EZ POC System check cartridge

IVD Class AIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133090633
Basic UDI-DI: 880613309063DS
Reference: FPCC154
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Austria
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:44

Manufacturer products Authorised representative products Authorised representative actors View details

ez-Tracker System check cartridge

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133081389
Basic UDI-DI: 880613308138DR
Reference: ET001-SC
EMDN: W0201020180
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:44

Manufacturer products Authorised representative products Authorised representative actors View details

30 μL Capillary tube

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133080917
Basic UDI-DI: 880613308091DQ
Reference: CFPO-21
EMDN: W0501010203
EMDN description: BLOOD COLLECTION, CAPILLARY TUBES
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 12:44

Manufacturer products Authorised representative products Authorised representative actors View details