FDA device listing

Cold Pack,Hot Pack,Hot/Cold Pack,Cooling Gel Patch,fever cooling gel patch

FDA device listing 1400347080 · Zhejiang Lidesen Medical Instrument Co., Ltd

Key facts

Proprietary names Cold Pack,Hot Pack,Hot/Cold Pack,Cooling Gel Patch,fever cooling gel patch
Owner/operator Zhejiang Lidesen Medical Instrument Co., Ltd
Owner/operator number 10090389
Product codes IMD
Device names IMD - Pack, Hot Or Cold, Disposable
Device class Class I
Classification regulations (21 CFR) 890.5710
Review panels Physical Medicine
Registered establishments ZHEJIANG LIDESEN MEDICAL INSTRUMENT CO., LTD
Establishment registrations 3031184338
FEI numbers 3031184338
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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