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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

SCREENINGTOOL — Class IIa MDR by Oiva Health Oy

MD Atlas
Oiva Health Oy

EUDAMED last updated this device on Jan 28, 2026

SCREENINGTOOL

6429811363SCREENINGTOOL29

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Oiva Health Oy
UDI-DI code: 06429811363007
Reference / catalog number: SCREENINGTOOL

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Manufacturer information

Organization name: Oiva Health Oy
SRN: FI-MF-000045801
Manufacturer status: Active

Market distribution

Primary placement in Finland; available across 1 country total.

Country	On market since	Until
FinlandPrimary placement	Feb 3, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 06429811363007
Basic UDI-DI: 6429811363SCREENINGTOOL29
Reference / catalog number: SCREENINGTOOL
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Screening Tool is a collection of self-assessment questionnaires related to medical conditions such as anxiety, cardiovascular diseases, depression, and diabetes. The purpose is to screen potential candidates for further studies. A healthcare professional selects a questionnaire from the collection for a healthcare customer to fill out. Based on the result obtained from the questionnaire, the healthcare professional can suggest further examinations to the patients, which may eventually lead to a diagnosis.
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

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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.