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Gerätelisting

Die Pflicht für Hersteller, ihre Medizinprodukte bei der FDA zu listen.

Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy

Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.

WHEN IT APPLIES

Device listing is the FDA requirement to identify devices an establishment is involved with, complementary to establishment registration.

PROCESS / STEPS

  1. List each device proprietary name/product code as required.
  2. Keep listings current after ownership or device changes.
  3. Coordinate with UDI/GUDID data where applicable.

EXAMPLES

  • Contract manufacturers and specification developers may have distinct listing obligations.

RELATED GUIDES & TOOLS

SOURCES

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VERWANDTE BEGRIFFE

BetriebsregistrierungFDA-Produktcode