FDA device listing

GUIA DE SUERO - PERFUS MACROGOTERO V14,IV CATHETER GUIDE - MACRODRIP PERFUSION SET V14

FDA device listing 1239447807 · Hynaut Health Technology Co., LTD.

Key facts

Proprietary names GUIA DE SUERO - PERFUS MACROGOTERO V14,IV CATHETER GUIDE - MACRODRIP PERFUSION SET V14
Owner/operator Hynaut Health Technology Co., LTD.
Owner/operator number 10040387
Product codes JCY
Device names JCY - Catheter, Infusion
Device class Class I
Classification regulations (21 CFR) 878.4200
Review panels General & Plastic Surgery
Registered establishments Hynaut Health Technology Co., LTD.
Establishment registrations 3008808560
FEI numbers 3004601847
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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