FDA device listing

Wipes

FDA device listing 1717155938 · Kilo-Promise Healthcare (Shandong) Co.,Ltd.

Key facts

Proprietary names Wipes
Owner/operator Kilo-Promise Healthcare (Shandong) Co.,Ltd.
Owner/operator number 10087398
Product codes LRJ
Device names LRJ - Disinfectant, Medical Devices
Device class Class I
Classification regulations (21 CFR) 880.6890
Review panels General Hospital
Registered establishments KILO-PROMISE HEALTHCARE (SHANDONG) CO.,LTD.
Establishment registrations 3026858378
FEI numbers 3026858378
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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