FDA device listing

RUMEX OPHTHALMIC INSTRUMENTS,RUMEX OPHTHALMIC KNIFE

FDA device listing 1656762076 · Rumex International Co.

Key facts

Proprietary names RUMEX OPHTHALMIC INSTRUMENTS,RUMEX OPHTHALMIC KNIFE
Owner/operator Rumex International Co.
Owner/operator number 9011770
Product codes HNN
Device names HNN - Knife, Ophthalmic
Device class Class I
Classification regulations (21 CFR) 886.4350
Review panels Ophthalmic
Registered establishments Perfect Ophthalmic Instruments FZE, RUMEX Baltics SIA, RUMEX INTERNATIONAL CO.
Establishment registrations 1058726, 3012185136, 3031231776
FEI numbers 1000307733, 3012185136, 3031231776
Establishment operations Manufacturer, Repackager/Relabeler
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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