FDA device listing

Convatec

FDA device listing 1743642618 · HI MEDICAL CO., LTD.

Key facts

Proprietary names Convatec
Owner/operator HI MEDICAL CO., LTD.
Owner/operator number 10052106
Product codes NAC
Device names NAC - Dressing, Wound, Hydrophilic
Device class Class I
Classification regulations (21 CFR) 878.4018
Review panels General & Plastic Surgery
Registered establishments HI MEDICAL CO., LTD.
Establishment registrations 3012502601
FEI numbers 3012502601
Establishment operations Foreign Exporter
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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