FDA device listing

ice bag

FDA device listing 1613608429 · CHANGZHOU HOLYMED PRODUCTS CO., LTD

Key facts

Proprietary names ice bag
Owner/operator CHANGZHOU HOLYMED PRODUCTS CO., LTD
Owner/operator number 10024103
Product codes KYR
Device names KYR - Bag, Ice
Device class Class I
Classification regulations (21 CFR) 880.6050
Review panels General Hospital
Registered establishments CHANGZHOU HOLYMED PRODUCTS CO., LTD
Establishment registrations 3006891803
FEI numbers 3006891803
Establishment operations Contract Manufacturer, 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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