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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

AD7-020 — IVDR Class A IVDR by ArcDia International Oy…

MD Atlas
ArcDia International Oy Ltd

EUDAMED last updated this device on Dec 7, 2022

AD7-020

643008037AD7-020HF

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: ArcDia International Oy Ltd
UDI-DI code: 06430080370412
Reference / catalog number: AD7-020

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Manufacturer information

Organization name: ArcDia International Oy Ltd
SRN: FI-MF-000007553
Manufacturer status: Active

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW011
Dangerous invisible laser radiation inside. Do not dismantle. No user serviceable parts inside. Class I laser product EN 60825-1:2014

Market distribution

Primary placement in Finland; available across 1 country total.

Placed on the market in Finland; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 06430080370412
Basic UDI-DI: 643008037AD7-020HF
Reference / catalog number: AD7-020
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The intended use of the mariPOC® Analyser AD7-020 is automated sample dispensing fluorometry based on two-photon excitation assay technique. The fluorometer measures, separation-free, fluorescence signal from the surface of individual microparticles able to scatter excitation light and from the aqueous solution around the microparticles from the reaction wells of mariPOC® test plates. mariPOC® Analyser functions as an in vitro diagnostic device when used in combination with mariPOC® test reagents. The Analyser's functions are automated and controlled by the external mariPOC® Software and the embedded software that control the measurement process. The sensory data is quantitative in nature and the fluorescence brightness of the particles depends quantitatively on the target molecule concentration. The sensory data is transmitted by the embedded software to the mariPOC® Software, where it is processed into objective results. The results are presented on the graphical user interface of the mariPOC® Software either qualitatively or semi-quantitatively.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0201020299LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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