FDA device listing

Container, Specimen, Sterile

FDA device listing 1418060543 · JIE GAO MEDICAL PLASTIC PRODUCTS (MALAYSIA) SDN. BHD.

Key facts

Proprietary names Container, Specimen, Sterile
Owner/operator JIE GAO MEDICAL PLASTIC PRODUCTS (MALAYSIA) SDN. BHD.
Owner/operator number 10093557
Product codes FMH
Device names FMH - Container, Specimen, Sterile
Device class Class I
Classification regulations (21 CFR) 864.3250
Review panels Pathology
Registered establishments JIE GAO MEDICAL PLASTIC PRODUCTS (MALAYSIA) SDN. BHD.
Establishment registrations 3038613790
FEI numbers 3038613790
Establishment operations Contract 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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