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ELISA-VIDITEST anti-Chlamydia pneumoniae IgG

IVD Annex II List BIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 28594036044573
Basic UDI-DI: B-28594036044573
Reference: ODZ-457
EMDN: W0105010115
EMDN description: CHLAMYDIA PNEUMONAIE ANTIBODY IGG
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 16:22

Manufacturer products View details

ELISA-VIDITEST anti-Chlamydia trachomatis IgG

IVD Annex II List BIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 28594036044542
Basic UDI-DI: B-28594036044542
Reference: ODZ-464
EMDN: W0105010110
EMDN description: CHLAMYDIA TRACHOMATIS ANTIBODY IGG
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 16:21

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ELISA-VIDITEST anti-Borelia recombinant IgG + VIsE (CSF)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 28594036043989
Basic UDI-DI: B-28594036043989
Reference: ODZ-398
EMDN: W0105010603
EMDN description: LYME ANTIBODY IGG
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 16:21

Manufacturer products View details

ELISA-VIDITEST anti-Borelia recombinant IgM (CSF)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 28594036043996
Basic UDI-DI: B-28594036043996
Reference: ODZ-399
EMDN: W0105010604
EMDN description: LYME ANTIBODY IGM
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 16:21

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ELISA-VIDITEST anti-Mycoplasma pneumoniae IgA

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 28594036040124
Basic UDI-DI: B-28594036040124
Reference: ODZ-012
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 16:20

Manufacturer products View details

ELISA-VIDITEST anti-Mycoplasma pneumoniae IgM

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 28594036040117
Basic UDI-DI: B-28594036040117
Reference: ODZ-011
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 16:20

Manufacturer products View details

ELISA-VIDITEST anti-Mycoplasma pneumoniae IgG

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 28594036040100
Basic UDI-DI: B-28594036040100
Reference: ODZ-010
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 16:20

Manufacturer products View details

Tuberculosis Interferon-Gamma Release Assay Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 20850076346441
Basic UDI-DI: B-20850076346441
Reference: CCTBIG-401a
EMDN: W0105010704
EMDN description: TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 15:03

Manufacturer products Authorised representative products Authorised representative actors View details

mariPOC® CDI test plate

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: D-2037MGY
Basic UDI-DI: B-2037MGY
Reference: 2037M
EMDN: W0105011803
EMDN description: C.DIFFICILE GDH AND TOXIN A/B COMBINED DETECTION
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 14:28

Manufacturer products View details

mariPOC® Pneumococcus respiratory test reagent

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: D-1R11EG
Basic UDI-DI: B-1R11EG
Reference: 1R11
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 14:26

Manufacturer products View details

mariPOC® Group A streptococcus test reagent

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: D-1R02EF
Basic UDI-DI: B-1R02EF
Reference: 1R02
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 14:17

Manufacturer products View details

Rapid Mycoplasma Pneumoniae Antigen Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-1O26C5YS
Basic UDI-DI: B-1O26C5YS
Reference: 1O26C5-1-EU,1O26C5-20-EU
EMDN: W0105010801
EMDN description: MYCOPLASMA ANTIGEN DETECTION
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 11.07.2026 14:17

Manufacturer products Authorised representative products Authorised representative actors View details

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