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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

PIRKKO — Class I MDD by Integritas Oy

MD Atlas
Integritas Oy

EUDAMED last updated this device on Apr 7, 2022

PIRKKO

B-PIRKKOP8

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Integritas Oy
UDI-DI code: D-PIRKKOP8
Reference / catalog number: PIRKKO

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Manufacturer information

Organization name: Integritas Oy
SRN: FI-MF-000012405
Manufacturer status: Active

Critical warnings

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

CW011
PIRKKO®-järjestelmä on toiminnanohjausjärjestelmä, ei ensisijainen potilastietojärjestelmä. Kaikki hoitotiedot löytyvät organisaation käytössä olevasta potilastietojärjestelmästä. Kaikki hoitopäätökset tehdään aina useasta eri lähteestä kerättyyn tietoon nojaten, mukaan lukien potilaan haastattelu. Näin ollen PIRKKO®-järjestelmän virhetilanteet voivat johtaa vain vähäiseen potilasturvallisuuden haittatapahtumaan. PIRKKO® -järjestelmä ei tue Internet Explorer -selaimen käyttöä ja kirjautuminen tällä selaimella on estetty.

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: D-PIRKKOP8
Basic UDI-DI: B-PIRKKOP8
Reference / catalog number: PIRKKO
Issuing entity: EUDAMED

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Ohjelmistopalvelu, joka on tarkoitettu hoitosuunnitelmien analysointiin, optimointiin ja seurantaan mielenterveys-, päihde- ja perhepalveluissa. Ratkaisu on tarkoitettu erityisesti sellaisiin sosiaali- ja terveydenhuollon palveluihin, joissa potilailla tai potilailla on krooninen sairaus tai pitkäaikaisia sosiaalisia ongelmia tai he hyötyvät hoidon moniammatillisesta koordinoinnista. Tuote on tarkoitettu tarjoamaan tietoa terveydenhuollon ammattihenkilölle hoitopäätösten tueksi.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z129092VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE

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

This device is not currently linked to any other device.

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.