FDA device listing

Gri-fill

FDA device listing 1530172625 · LABORATORIOS GRIFOLS, S.A.

Key facts

Proprietary names Gri-fill
Owner/operator LABORATORIOS GRIFOLS, S.A.
Owner/operator number 9056285
Product codes NEP
Device names NEP - System/Device, Pharmacy Compounding
Device class Class II
Classification regulations (21 CFR) 880.5440
Review panels General Hospital
Registered establishments LABORATORIOS GRIFOLS, S.A.
Establishment registrations 3002807257
FEI numbers 3002807257
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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