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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

1204SC — IVDD — General IVDD by ArcDia International Oy…

MD Atlas
ArcDia International Oy Ltd

EUDAMED last updated this device on Jan 5, 2026

1204SC

B-1204SCQQ

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: ArcDia International Oy Ltd
UDI-DI code: D-1204SCQQ
Reference / catalog number: 1204SC

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Manufacturer information

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

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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: D-1204SCQQ
Basic UDI-DI: B-1204SCQQ
Reference / catalog number: 1204SC
Issuing entity: EUDAMED

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: mariPOC SARS-2 control samples is intended for use as known process control samples in the mariPOC SARS-CoV-2 test. Package includes bar-coded positive and negative sample tubes. The positive control sample contains non-infectious SARS-CoV-2 antigen. Product is part of a closed multianalyte mariPOC test system intended to be used for rapid detection of acute respiratory tract infection pathogens using antigen detection. Assay technique is based on two-photon excitation of fluorescence. For laboratory use.
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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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.