FDA device listing

Knife, Myringotomy

FDA device listing 1390702777 · HEALTHIUM MEDTECH LIMITED

Key facts

Owner/operator HEALTHIUM MEDTECH LIMITED
Owner/operator number 9064005
Product codes JYP
Device names JYP - Knife, Myringotomy
Device class Class I
Classification regulations (21 CFR) 874.4420
Review panels Ear, Nose, & Throat
Registered establishments PARAMOUNT SURGIMED LTD.
Establishment registrations 9680889
FEI numbers 1000388472
Establishment operations 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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