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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

Oma02 — Class IIb MDR by DigiFinland Oy

MD Atlas
DigiFinland Oy

EUDAMED last updated this device on Feb 9, 2026

Oma02

6429810539Oma02H3

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: DigiFinland Oy
UDI-DI code: 06429810539045
Reference / catalog number: Oma02

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Manufacturer information

Organization name: DigiFinland Oy
SRN: FI-MF-000002451
Manufacturer status: Active

Market distribution

Primary placement in Finland; available across 1 country total.

Country	On market since	Until
FinlandPrimary placement	Feb 10, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 06429810539045
Basic UDI-DI: 6429810539Oma02H3
Reference / catalog number: Oma02
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: Omaolo on Suomessa vakituisesti asuville ja julkisiin sosiaali- ja terveyspalveluihin oikeutetuille henkilöille suunnattu sähköinen palvelu. Omaolon käyttötarkoitus on asukkaan hoidon tarpeen ja kiireellisyyden arviointi seuraavissa tilanteissa: yksittäisen terveysongelman tai useiden oireiden arviointi, terveyden ja hyvinvoinnin arviointi, hoitotasapainon, sairauden tai sen riskien arviointi ja asukkaan ohjaus hoidon piiriin terveyttä ja hyvinvointia edistäviin palveluihin. Omaoloon integroidaan muita lääkinnällisiä laitteita, keskeisimpänä Kustannus Oy Duodecimin valmistama EBMEDS-laite.
Additional information URL: https://www.omaolo.fi/
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

Navi016429810539Navi01YGOn the market

Certificates

Certificate health across this manufacturer's portfolio.

FI22/871876Supplemented
Quality management systemNotified body: 0598Expiry: May 15, 2028
FI22/871876Supplemented
Quality management systemNotified body: 0598Expiry: May 15, 2025