FDA device listing

Shield, Protective, Personnel

FDA device listing 2022962329 · Skytech Creations Limited

Key facts

Owner/operator Skytech Creations Limited
Owner/operator number 10058350
Product codes KPY
Device names KPY - Shield, Protective, Personnel
Device class Class I
Classification regulations (21 CFR) 892.6500
Review panels Radiology
Registered establishments Skytech Electronics (HK) Limited
Establishment registrations 3014700242
FEI numbers 3014700242
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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