Manufacturer

Arcdia

FinlandLegal entities : ArcDia International Oy Ltd

Markets : Finland

Approvals : EU – class A

23 categories, 52 models including 46 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Limited panel immunochemistry analysers - other	W0201020299	mariPOC® Analyser mariPOC® Bottletop dispenser stand mariPOC® Filtration unit rack mariPOC® Gastro control samples98/79 mariPOC® Pharyn control samples98/79 4 others mariPOC® Quick Flu+ control samples mariPOC® RTI control samples98/79 mariPOC® Test plate storage rack mariPOC® SARS-2 control samples98/79 (no longer marketed)	A IVDR, 98/79	EUDAMED record Report an error
Multiple infectious - multiplex assays - other	W0105070599	mariPOC® Gastro CDI combi test plate98/79 mariPOC® Gastro test plate98/79 mariPOC® Pharyn test plate98/79 mariPOC® Quick combi+ test plate98/79 mariPOC® Respi+ test plate2 refs98/79 1 other mariPOC® RTI combi+ test plate98/79	A IVDR, 98/79	EUDAMED record Report an error
Influenza & para influenza	W0105040604	mariPOC® Influenza A virus test reagent98/79 mariPOC® Influenza B virus test reagent98/79 mariPOC® Parainfluenza virus 1 test reagent98/79 mariPOC® Parainfluenza virus 2 test reagent98/79 mariPOC® Parainfluenza virus 3 test reagent98/79	– 98/79	EUDAMED record Report an error
IVD general use consumable devices - other	W0599	mariPOC® Gastro sample buffer mariPOC® RTI sample buffer mariPOC® System solution mariPOC® Wash solution	A IVDR	EUDAMED record Report an error
Buffers (unassignable ), supplem. reagents, etc	W0105900201	mariPOC® Extraction solution A mariPOC® Extraction solution B mariPOC® Inactivation solution	A IVDR	EUDAMED record Report an error
Adenovirus	W0105040601	mariPOC® Adenovirus gastrointestinal test reagent98/79 mariPOC® Adenovirus respiratory test reagent98/79	– 98/79	EUDAMED record Report an error
Coronavirus ag	W0105041101	mariPOC® Human coronavirus OC43 test reagent98/79 mariPOC® SARS-CoV-2 test reagent98/79	– 98/79	EUDAMED record Report an error
IVD general use consumables devices - other accessories	W0580	mariPOC® Sample tube cap mariPOC® Sample tube	A IVDR	EUDAMED record Report an error
Norovirus	W0105040616	mariPOC® Norovirus GI test reagent98/79 mariPOC® Norovirus GII.4 test reagent98/79	– 98/79	EUDAMED record Report an error
Streptococcal direct antigen detection	W0105011101	mariPOC® Group A streptococcus test reagent98/79 mariPOC® Pneumococcus respiratory test reagent98/79	– 98/79	EUDAMED record Report an error
Bocavirus	W0105040618	mariPOC® Human bocavirus test reagent98/79	– 98/79	EUDAMED record Report an error
C.difficile GDH and toxin a/b combined detection	W0105011803	mariPOC® CDI test plate98/79	– 98/79	EUDAMED record Report an error
C.difficile GDH detection	W0105011801	mariPOC® Clostridium difficile GDH test reagent98/79	– 98/79	EUDAMED record Report an error
C.difficile toxin a/b detection	W0105011802	mariPOC® Clostridium difficile Toxin A/B test reagent98/79	– 98/79	EUDAMED record Report an error
Campylobacter direct antigen detection	W0105011401	mariPOC® Campylobacter spp. test reagent98/79	– 98/79	EUDAMED record Report an error
Human metapneumovirus	W0105040617	mariPOC® Human metapneumovirus test reagent98/79	– 98/79	EUDAMED record Report an error
Limited panel immunochemistry analysers - hardware accessories	W0201020280	mariPOC® Waste container	A IVDR	EUDAMED record Report an error
Limited panel immunochemistry analysers - IVD medical device software	W0201020292	mariPOC® Software	A IVDR	EUDAMED record Report an error
Respiratory syncytial virus (rsv)	W0105040605	mariPOC® Respiratory syncytial virus test reagent98/79	– 98/79	EUDAMED record Report an error
Rotavirus	W0105040606	mariPOC® Rotavirus test reagent98/79	– 98/79	EUDAMED record Report an error
Multiple viruses - other No model still on the market	W01050799	mariPOC® Quick Flu+ test plate (no longer marketed) mariPOC® Respi test plate (no longer marketed)	A IVDR	EUDAMED record Report an error
Respiratory tract infections - multiplex NA reagents No model still on the market	W0105070503	mariPOC® Quick combi test plate (no longer marketed) mariPOC® RTI combi test plate (no longer marketed)	A IVDR	EUDAMED record Report an error
Virology - RT & POC - other No model still on the market	W0105099099	mariPOC® SARS-CoV-2 test plate98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error

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