FDA device listing

Hydrogel Gauze

FDA device listing 1898056615 · Nanjing Anjian Medical Device Co.,Ltd.

Key facts

Proprietary names Hydrogel Gauze
Owner/operator Nanjing Anjian Medical Device Co.,Ltd.
Owner/operator number 10059266
Product codes NAE
Device names NAE - Dressing, Wound, Hydrogel Without Drug And/Or Biologic
Device class Class I
Classification regulations (21 CFR) 878.4022
Review panels General & Plastic Surgery
Registered establishments NANJING ANJIAN MEDICAL DEVICE CO.,LTD.
Establishment registrations 3015142802
FEI numbers 3015142802
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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