Generated Narrative: Device device-riskassist-ai

Third-Country Data Transfer
transferFlag: false

Model Card Reference: DocumentReference: extension = Not Clinically Validated,,,; status = current; type = AI Model Card; description = Synthetic model card for a deterministic AI-output simulation component used in the PoC.

identifier: EU AI Database Identifier/EU-AI-000123

status: Active

manufacturer: ExampleMed AI GmbH

Value

Type

Display

RiskAssist AI

Registered name

true

Value

1.0.0

Category

Specification

quality-management-system

Synthetic QMS certification reference for PoC purposes.

property
type: CE Mark
value: true

property
type: Notified Body ID
value: NB-0000

property
type: Expected Lifetime
value: 5 years (Details: UCUM codea = 'a')

property
type: Medical Purpose
value: Supportive risk stratification in acute care settings

property
type: Target Population
value: Adult patients with suspected infection in an acute care setting

owner: Organization Example Hospital

contact: contact@examplemed.example, dpo@examplemed.example

note: ,

Synthetic maintenance information for PoC purposes.

AI-assisted early warning risk assessment based on synthetic NEWS2-inspired vital parameters.