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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

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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

Manufacturer products Authorised representative products Authorised representative actors View details

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

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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

Manufacturer products Authorised representative products Authorised representative actors View details

GlucoDr.PRO™ BLE Control Solution

ABM-514P

IVD Class CIVDR 2017/746On the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: All Medicus Co., Ltd.
Manufacturer SRN: KR-MF-000020833
UDI-DI: 08806128351404
Basic UDI-DI: 88061283ABM514PCF6
Reference: ABM-514P-C1-S1
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Safety summary (SSCP/SSP): AM-TD-G05-06 · Rev. 01
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.08.2026 00:00

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

GlucoDr.PRO™ BLE Blood Glucose Test Strip

ABM-514P

IVD Class CIVDR 2017/746On the marketNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: All Medicus Co., Ltd.
Manufacturer SRN: KR-MF-000020833
UDI-DI: 08806128351428
Basic UDI-DI: 88061283ABM514PSG6
Reference: ABM-514P-S1-P2
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Safety summary (SSCP/SSP): AM-TD-G05-06 · Rev. 01
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.08.2026 00:00

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

GlucoDr.PRO™ Blood Glucose Test Strip

AGM-514P

IVD Class CIVDR 2017/746On the marketNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: All Medicus Co., Ltd.
Manufacturer SRN: KR-MF-000020833
UDI-DI: 08806128351329
Basic UDI-DI: 88061283AGM514PSJT
Reference: AGM-514P-S1-P2
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Safety summary (SSCP/SSP): AM-TD-G07-06 · Rev. 02
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.08.2026 00:00

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

GlucoDr.PRO™ Control Solution

AGM-514P

IVD Class CIVDR 2017/746On the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: All Medicus Co., Ltd.
Manufacturer SRN: KR-MF-000020833
UDI-DI: 08806128351305
Basic UDI-DI: 88061283AGM514PCHT
Reference: AGM-514P-C1-S1
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Safety summary (SSCP/SSP): AM-TD-G07-06 · Rev. 02
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.08.2026 00:00

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

GlucoDr.S™ BLE Blood Glucose Test Strip

ABM-513S

IVD Class CIVDR 2017/746On the marketNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: All Medicus Co., Ltd.
Manufacturer SRN: KR-MF-000020833
UDI-DI: 08806128350629
Basic UDI-DI: 88061283ABM513SSGA
Reference: ABM-513S-S1-P2
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Safety summary (SSCP/SSP): AM-TD-G11-06 · Rev. 01
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.08.2026 00:00

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

GlucoDr.S™ BLE Control Solution

ABM-513S

IVD Class CIVDR 2017/746On the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: All Medicus Co., Ltd.
Manufacturer SRN: KR-MF-000020833
UDI-DI: 08806128350605
Basic UDI-DI: 88061283ABM513SCFA
Reference: ABM-513S-C1-S1
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Safety summary (SSCP/SSP): AM-TD-G11-06 · Rev. 01
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.08.2026 00:00

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

GlucoDr.S™ Blood Glucose Test Strip

AGM-513S

IVD Class CIVDR 2017/746On the marketNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: All Medicus Co., Ltd.
Manufacturer SRN: KR-MF-000020833
UDI-DI: 08806128350421
Basic UDI-DI: 88061283AGM513SSJX
Reference: AGM-513S-S1-P2
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Safety summary (SSCP/SSP): AM-TD-G06-06 · Rev. 04
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 23:59

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

GlucoDr.S™ Control Solution

AGM-513S

IVD Class CIVDR 2017/746On the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: All Medicus Co., Ltd.
Manufacturer SRN: KR-MF-000020833
UDI-DI: 08806128350407
Basic UDI-DI: 88061283AGM513SCHX
Reference: AGM-513S-C1-S1
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Safety summary (SSCP/SSP): AM-TD-G06-06 · Rev. 04
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 31.07.2026 23:59

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details