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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

B03B — IVDR Class A IVDR by ArcDia International Oy…

MD Atlas
ArcDia International Oy Ltd

EUDAMED last updated this device on Dec 7, 2022

B03B

643008037B03BXN

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: 06430080370368
Reference / catalog number: B03B

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Manufacturer information

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

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A-2643008037A-292On the market 2R01B-2R01ELOn the market 1R01B-1R01EDOn the market AD7-020643008037AD7-020HFOn the market A-29643008037A-29WDOn the market

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.

CW007
EUDAMED did not publish a description for this code.
CW010
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: 06430080370368
Basic UDI-DI: 643008037B03BXN
Reference / catalog number: B03B
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 mariPOC® Extraction solutions A and B are to be used in combination with each other in volumetric one-to-one portion. The intended use of the combination of the Extraction solution A and B is to extract the Lancefield's carbohydrate antigen of Group A streptococcus (StrpA reagent). The extraction solutions are used for sample pretreatment in Pharyn and Quick StrepA test reagent configurations.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105900201BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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