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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

AD1-S — IVDR Class A IVDR by ArcDia International Oy…

MD Atlas
ArcDia International Oy Ltd

EUDAMED last updated this device on Dec 7, 2022

AD1-S

643008037AD1-ST3

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: 06430080370429
Reference / catalog number: AD1-S

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Manufacturer information

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

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: 06430080370429
Basic UDI-DI: 643008037AD1-ST3
Reference / catalog number: AD1-S
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® Software named ArcDiagnoser™ is to archive and process sensory data of the mariPOC® Analyser measured from mariPOC® test reagents on test plate(s), as well as the associated patient information, in accordance with the commands fed by the user through the graphical user interface or laboratory information connection. mariPOC® Software functions as an in vitro diagnostic device when used in combination with mariPOC® test reagents and Analyser. mariPOC® Software is a stand-alone software for the mariPOC® test system, that provides the main graphical user interface (GUI), and additionally controls the automated functions of the mariPOC® Analyser and the end user operations. It objectively reports the results qualitatively and/or semiquantitatively on the graphical user interface, and enables data transfer between other IT systems.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0201020292LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWAE

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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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.