From device description to regulatory direction — in seconds.
Describe a medical device and get an instant view of likely FDA classification, product codes, and premarket pathway — alongside high-level EU MDR and UK considerations. Built for early-stage triage by regulatory, R&D, and product teams.
Describe your device
Informational only — not legal or regulatory advice. Results are AI-generated and may be incomplete or incorrect. Always confirm classification, product codes, and pathway with the FDA, the relevant EU Notified Body / MHRA, and qualified regulatory counsel.