Nyelux vs EUDAMED

Nyelux is a medical device intelligence platform built for healthcare professionals. Search FDA-registered devices, follow manufacturers, get FDA recall and 510(k) clearance updates, and chat with a clinical AI that cites every claim. For verified HCPs only. Nyelux requires HCP credential verification before access to PHI features. Verification typically takes 1-2 business days. What you can do • Search across the full FDA GUDID device catalog by name, manufacturer, or catalog number. • Follow manufacturers and see their assigned reps, recent 510(k) clearances, and recalls in one feed. • Ask the Nyelux AI clinical questions about devices, indications, comparisons, and safety data — every answer is grounded in source citations. • Capture preference cards for procedures: primary, backup, and optional devices, with shared access for your team. • Take notes with photo and voice attachments — encrypted at rest, redacted from screenshots and the App Switcher preview. • Message verified manufacturer reps directly when you need device-specific support. Privacy & security Nyelux is built for HIPAA. PHI lives only in memory or end-to-end encrypted storage; the app auto-locks on inactivity, requires Face ID for sensitive surfaces, and never logs patient identifiers.

Search the European medical device database from your phone. EUDAMED App gives you fast, read-only access to the public data of the European Database on Medical Devices. Whether you're standing in a stockroom with a device in your hand or reviewing a supplier at your desk, you get the registered facts in seconds — no login, no account, no setup. SCAN A LABEL Point the camera at the UDI barcode or QR code on a device label. The app parses the application identifiers, extracts the UDI and looks the device up directly in EUDAMED. No barcode at hand? Type the UDI manually. FIND DEVICES Search the device registry by: • Reference or catalogue number • Device trade name • Actor ID / SRN of the manufacturer • Primary DI • Basic UDI-DI (the device family identifier) • EMDN nomenclature code Combine criteria to narrow down large result sets, and see the registered details: device name, risk class, nomenclature, status and the responsible economic operator. FIND ACTORS Look up the economic operators behind a device — manufacturers, authorised representatives, importers and producers of system/procedure packs. Filter by legal name, SRN, actor type, registration status and country of registration. BUILT FOR THE JOB • Recent searches saved per field, so repeat lookups take one tap • Clean, native iOS design — no clutter, no ads • Results come straight from the official public API, so you always see the current registered state • Read-only by design: the app never submits, edits or registers anything WHO IT'S FOR • Regulatory affairs and quality teams — check registration status, Basic UDI-DI groupings and EMDN assignments for your own portfolio or a competitor's. • Hospital procurement and biomedical engineering — confirm a device on the shelf is registered, and see which operator is responsible for it. • Distributors and importers — verify a manufacturer's SRN and the actor chain behind a product before you take it on. • Notified body staff and anyone who needs a registration checked away from a desk will find it just as useful — scan the label, get the answer. PRIVACY No account. No tracking. No analytics. Your searches stay on your device. IN-APP PURCHASE Searching devices and actors in the EUDAMED database is always free and unlimited. The first 20 UDI barcode scans are included. After that, a single one-time purchase unlocks unlimited scanning. No subscription. No recurring fees. Buy once, use forever. Restores automatically on your other devices. DISCLAIMER EUDAMED Mobile is an independent application and is not affiliated with, endorsed by, or operated by the European Commission. Data is retrieved from the publicly available EUDAMED interface and is provided for information purposes only — it is not a substitute for the official database or for regulatory advice.