FDA device listing

Max Mara, Elsav

FDA device listing 2063425802 · Max Mara S.R.L.

Key facts

Proprietary names Max Mara, Elsav
Owner/operator Max Mara S.R.L.
Owner/operator number 10052213
Product codes HOI
Device names HOI - Spectacle, Magnifying
Device class Class I
Classification regulations (21 CFR) 886.5840
Review panels Ophthalmic
Registered establishments MAX MARA S.R.L.
Establishment registrations 3012262775
FEI numbers 3012262775
Establishment operations Foreign Exporter
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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