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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

1104MC — IVDD — General IVDD by ArcDia International Oy…

MD Atlas
ArcDia International Oy Ltd

EUDAMED last updated this device on Jan 5, 2026

1104MC

B-1104MCPT

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-1104MCPT
Reference / catalog number: 1104MC

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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

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

CW007
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW008
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-1104MCPT
Basic UDI-DI: B-1104MCPT
Reference / catalog number: 1104MC
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 RTI control samples is intended for use as known process control samples in mariPOC respiratory infection tests. Package includes positive and negative control sample dried in a flocked swab inside a bar coded tube. Positive control sample includes all analytes in the mariPOC respiratory infection tests. 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

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