FDA device listing

Pack, hot or cold, reusable

FDA device listing 2055107699 · Hospital & Homecare Imp. & Exp. Co., Ltd

Key facts

Proprietary names Pack, hot or cold, reusable
Owner/operator Hospital & Homecare Imp. & Exp. Co., Ltd
Owner/operator number 10024296
Product codes IME
Device names IME - Pack, Hot Or Cold, Reusable
Device class Class I
Classification regulations (21 CFR) 890.5700
Review panels Physical Medicine
Registered establishments HOSPITAL & HOMECARE IMP. & EXP. CO., LTD
Establishment registrations 3006897996
FEI numbers 3006897996
Establishment operations Foreign Exporter
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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