FDA device listing

Goggles

FDA device listing 1611527910 · Shenzhen Med-Link Electronics Tech Co.,Ltd

Key facts

Proprietary names Goggles
Owner/operator Shenzhen Med-Link Electronics Tech Co.,Ltd
Owner/operator number 10030237
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 SHENZHEN MED-LINK ELECTRONICS TECH CO.,LTD
Establishment registrations 3006636961
FEI numbers 3006636961
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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