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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

Navi01 — Class IIb MDR by DigiFinland Oy

MD Atlas
DigiFinland Oy

EUDAMED last updated this device on Dec 10, 2025

Navi01

6429810539Navi01YG

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: DigiFinland Oy
UDI-DI code: 06429810539038
Reference / catalog number: Navi01

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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	Dec 16, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 06429810539038
Basic UDI-DI: 6429810539Navi01YG
Reference / catalog number: Navi01
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: Navigaattoripalvelun käyttötarkoitus on kerätä ja jäsentää tietoja asukkailta, jotka hakeutuvat terveyspalveluihin mielenterveysongelmien tai psyykkisen ahdingon vuoksi. Navigaattoripalvelun yhteenvetoraportin perusteella asukas voi saada tietoa omasta tilasta ja hakeutua terveydenhuollon vastaanotolle tai tutustua yleisiin omahoitomateriaaleihin. Sovellus ei tuota diagnoosia tai yksilöllistä ohjausta, mutta palvelun tuottamat tiedot ohjaavat terveydenhuollon ammattilaisen tekemää kliinistä arviota eli ensijäsennystä. Hoidon tarpeen arvioinnin tekee aina terveydenhuollon ammattihenkilö kliinisen haastattelun perusteella.
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

Oma026429810539Oma02H3On 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.