FDA device listing

Foam dressing, Super Absorbent Dressing, Hydrocolloid Dressing, Adhesive Island Dressing, Nasal Strips, Acne…

FDA device listing 1033411671 · HongYu BioTech (ShenZhen) Co., Ltd

Key facts

Proprietary names Foam dressing, Super Absorbent Dressing, Hydrocolloid Dressing, Adhesive Island Dressing, Nasal Strips, Acne Patch,,Hydrocolloid Gel Bandages,Transparent Film Dressing, Alginate Dressings, Film Island Dressing, Non-woven Adhesive Wound Dressing with pad,
Owner/operator HongYu BioTech (ShenZhen) Co., Ltd
Owner/operator number 10079513
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 HongYu BioTech (ShenZhen) Co., Ltd
Establishment registrations 3017107376
FEI numbers 3017107376
Establishment operations Contract Manufacturer, 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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