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ArcDia International Oy Ltd

Active in EUDAMED

Finlandfrom SRN EUDAMED SRN FI-MF-000007553

Devices
53
Registrations
EUDAMED

What ArcDia International Oy Ltd makes

ArcDia International Oy Ltd manufactures in vitro diagnostic (IVD) test systems for rapid pathogen detection, including sample tubes, analysers, test plates, and reagents. These products are designed for diagnosing acute infections, such as respiratory viruses (e.g., SARS-CoV-2, parainfluenza, respiratory syncytial virus) and bacterial infections (e.g., Group A streptococcus, *Clostridioides difficile*). The system allows simultaneous testing of multiple pathogens from a single clinical sample.

The company’s IVD devices fall under Class A and IVD General device classifications, with all products listed in the EU’s eudamed registry. The portfolio is regulated under EU IVD Regulation (IVDR) standards, ensuring compliance with diagnostic accuracy and safety requirements. The manufacturer is based in Finland.

AI-generated from registry data, 19 Sep 2026. Not verified by deviCERTS or the manufacturer.

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Company details

EUDAMED SRN
FI-MF-000007553
EU VAT number
FI19731524
EUDAMED status
Active
EUDAMED registered name
ArcDia International Oy Ltd
Registered address
32, Lemminkäisenkatu, 20520, Turku, Finland
Phone
+358406787414
PRRC contact
Mikko Tasanen(public in EUDAMED)

From the company website

Read 18 Sep 2026

mariPOC® test system enables fast and accurate diagnosis in acute infections. Multiple pathogens are tested from a single clinical sample simultaneously.

From the manufacturer's own website. Source