Where AI is named explicitly in the official device corpus
The monitor scans the public EUDAMED software corpus for exact AI text evidence. Manufacturer, risk, version and registry status remain separate observations—without deriving safety or conformity.
UDI
official production API
exact text evidence per candidate
no AI inference from “software”
no contact or PRRC data
Complete software corpus reviewedObserved since 23 July 2026
6,416official software records reviewed103candidates with text evidence60manufacturers in the candidate corpus3candidates with a full AI term
MOST RECENT OBSERVATIONS
What moved most recently
Every material change is recorded with the time it was observed. These are the most recent changes to named devices and manufacturers.
field changedVUNO Inc.Manufacturer status or version changed
new in the cohortAI Scribe (Nora module)Device candidate observed for the first time
no longer observedAccuRhythm AI ECG Classification SystemDevice no longer observed after two complete retrievals
127 material changes observed since the 23 July 2026 baseline.Full history →
THE DECISIVE BOUNDARY
A text match is not evidence of effectiveness or conformity.
An exact term shows only what the public device record says. Risk class, status, manufacturer and version describe that same registry entry, but no causal effect.
text evidence ≠ technical assessment · registry status ≠ conformity verdict
INTERACTIVE EVIDENCE TOPOLOGY
One device at the centre. Its published attributes around it.
Choose a candidate. The topology arranges fields from the same EUDAMED record—it claims neither causality nor certification.
Choose device
On small screens, scroll horizontally to explore the topology.
Clearly explained
+Does every software record in EUDAMED count as AI?
No. The monitor publishes a candidate only when an allowlisted public device field contains an exact AI term. Software classification, nomenclature, risk class and manufacturer name are never used as AI evidence.
+Does the monitor show certificate changes?
No. The current official public API exposes actor, reference and UDI/device operations, but no certificate or market-surveillance operation. The monitor leaves those lanes absent instead of inventing a link.
+Are first and last observed dates source change dates?
No. They are collector observation times. EUDAMED does not publish a source change timestamp in the records used here.
+Does the monitor judge safety or conformity?
No. A registry status, risk class or text match is not a safety, clinical-performance or conformity assessment.