FDA device listing

Cathaid Nextgen Hydrocolloid

FDA device listing 1629116786 · Hi-Tech Products de Mexico S.A. de C.V.

Key facts

Proprietary names Cathaid Nextgen Hydrocolloid
Owner/operator Hi-Tech Products de Mexico S.A. de C.V.
Owner/operator number 10052098
Product codes KMK
Device names KMK - Device, Intravascular Catheter Securement
Device class Class I
Classification regulations (21 CFR) 880.5210
Review panels General Hospital
Registered establishments HI-TECH PRODUCTS DE MEXICO S.A. DE C.V.
Establishment registrations 3008255748
FEI numbers 3008255748
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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