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Organization name
UDI-DI code
Reference / catalog number

Varfariinihoito — Class IIb MDR by Mediconsult Oy

MD Atlas
Mediconsult Oy

EUDAMED last updated this device on Apr 10, 2025

Varfariinihoito

6429810579MAREVANWR

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Mediconsult Oy
UDI-DI code: 64298105790416
Reference / catalog number: Varfariinihoito

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Manufacturer information

Organization name: Mediconsult Oy
SRN: FI-MF-000008741
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Finland; available across 1 country total.

Country	On market since	Until
FinlandPrimary placement	Feb 27, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 64298105790416
Basic UDI-DI: 6429810579MAREVANWR
Reference / catalog number: Varfariinihoito
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Marevan annoslaskurin (Sääntö 11, lk IIb), toiminnallisuus perustuu lääkäriseura Duodecimin sekä THLn julkaisemiin hoitosuosituksiin ”marevan laskuri”. Laskuri laskee uuden Marevan-annoksen potilaille, käyttäen aina oletuksena, että INR-hoitotaso on asetettu 2-3 välille. Jos INR-tavoitetaso on muu kuin 2-3 niin laskuria ei saa käyttää.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

Kliiniset laskurit (Saga)6429810579CLINCLCS6On the market Kliiniset laskurit6429810579CLINCLCS6On the market Lääkitys (Mediatri)6429810579MEDICTNT9On the market Lääkitys (Saga)6429810579MEDICTNT9On the market Varfariinihoito (Mediatri)6429810579MAREVANWROn the market

Certificates

Certificate health across this manufacturer's portfolio.

FI25/0000009Issued
Quality management systemNotified body: 0598Expiry: Feb 26, 2028