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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

A-43 — IVDR Class A IVDR by ArcDia International Oy…

MD Atlas
ArcDia International Oy Ltd

EUDAMED last updated this device on Dec 7, 2022

A-43

643008037A-43W7

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: 06430080370474
Reference / catalog number: A-43

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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.

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: 06430080370474
Basic UDI-DI: 643008037A-43W7
Reference / catalog number: A-43
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 purpose of the mariPOC® Test plate storage rack is to store mariPOC® test plates, which are still valid but removed from their original packaging, outside mariPOC® Analyser while another type of test plate (configuration package) is in use inside the mariPOC® Analyser.
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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Software identification