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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

AI-00002960 — Class I MDR by HUS-yhtymä

MD Atlas
HUS-yhtymä

EUDAMED last updated this device on Aug 18, 2025

AI-00002960

6438300OPU3

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: HUS-yhtymä
UDI-DI code: 06438300000040
Reference / catalog number: AI-00002960

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Manufacturer information

Organization name: HUS-yhtymä
SRN: FI-MF-000007401
Manufacturer status: Active

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: 06438300000040
Basic UDI-DI: 6438300OPU3
Reference / catalog number: AI-00002960
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Omapolku mobiili is an accessory for Omapolku. Omapolku mobiili is a mobile app that can be used to access Omapolku via mobile phone or a tablet. Omapolku provides digital care pathways for patients accessible with referral and remote appointments. These services complement traditional healthcare and appointments. Omapolku is a secure online service that uses strong identification.
Additional information URL: https://www.terveyskyla.fi/omapolku
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

AI-000028946438300ASQDVOn the market AI-000019576438300OPU3On 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.