FDA device listing

Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

FDA device listing 1711178482 · RZ MEDIZINTECHNIK GMBH

Key facts

Owner/operator RZ MEDIZINTECHNIK GMBH
Owner/operator number 9010855
Product codes HOY
Device names HOY - Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Device class Class I
Classification regulations (21 CFR) 886.4750
Review panels Ophthalmic
Registered establishments RZ MEDIZINTECHNIK GMBH
Establishment registrations 9680718
FEI numbers 3000280067
Establishment operations Contract 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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