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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

1224MC — IVDR Class A IVDR by ArcDia International Oy…

MD Atlas
ArcDia International Oy Ltd

EUDAMED last updated this device on Dec 7, 2022

1224MC

6430080371224MCCF

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: 06430080370528
Reference / catalog number: 1224MC

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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

2 warnings recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

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: 06430080370528
Basic UDI-DI: 6430080371224MCCF
Reference / catalog number: 1224MC
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® control samples is to provide follow-up data about the functionality of the mariPOC® Analyser and analysis process. The control samples are recommended to be run once a week or when needed for troubleshooting. The control samples are neither used to calibrate nor to verify the performance characteristics of the mariPOC® devices by the user. A control sample package includes one negative control (an empty tube) and one positive control (dried analyte/s in a tube). A positive control includes analytes for the test reagent configurations on the test plate that it is intended to be used with it. 1224MC mariPOC® Quick Flu+ control samples are used with 1224M test configuration packages.
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

UDI-PI traceability

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