FDA device listing

Nasal Aspirator, X1;

FDA device listing 2055626735 · TPH TECHNOLOGY MALAYSIA SDN. BHD.

Key facts

Proprietary names Nasal Aspirator, X1;
Owner/operator TPH TECHNOLOGY MALAYSIA SDN. BHD.
Owner/operator number 10090984
Product codes HGY
Device names HGY - Pump, Breast, Non-Powered
Device class Class I
Classification regulations (21 CFR) 884.5150
Review panels Obstetrics/Gynecology
Registered establishments TPH TECHNOLOGY MALAYSIA SDN. BHD.
Establishment registrations 3031566471
FEI numbers 3031566471
Establishment operations Repackager/Relabeler
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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