FDA device listing

Dressing, Wound, Drug

FDA device listing 1355630825 · Guangzhou Kaiheng K&S Co.,Ltd.

Key facts

Owner/operator Guangzhou Kaiheng K&S Co.,Ltd.
Owner/operator number 10055122
Product codes FRO
Device names FRO - Dressing, Wound, Drug
Device class Unclassified
Classification regulations (21 CFR) ORCA1.FRO
Review panels General & Plastic Surgery
Registered establishments GUANGZHOU KAIHENG K&S CO.,LTD.
Establishment registrations 3013671177
FEI numbers 3013671177
Establishment operations Contract Sterilizer
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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