FDA device listing

12 patches/box, 14 patches/box, 16 patches/box, 18 patches/box, 20 patches/box, 22 patches/box, 24 patches/box,,26…

FDA device listing 1640742217 · Guangdong Kelihuan Biotechnology Co., Ltd.

Key facts

Proprietary names 12 patches/box, 14 patches/box, 16 patches/box, 18 patches/box, 20 patches/box, 22 patches/box, 24 patches/box,,26 patches/box, 28 patches/box, 30 patches/box,Essential Oil Patches 2 patches/bag, 4 patches/bag, 4 patches/box, 6 patches/box, 8 patches/box, 10 patches/box,
Owner/operator Guangdong Kelihuan Biotechnology Co., Ltd.
Owner/operator number 10095925
Product codes KCJ
Device names KCJ - Applicator, Ent
Device class Class I
Classification regulations (21 CFR) 874.5220
Review panels Ear, Nose, & Throat
Registered establishments GUANGDONG KELIHUAN BIOTECHNOLOGY CO., LTD.
Establishment registrations 3045975099
FEI numbers 3045975099
Establishment operations Foreign Exporter, 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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