FDA device listing

Non-woven Tape; non-woven surgical tape; PE Tape; transparent surgical tape; I.V Dressing; Silicone Tape,Surgical Tape…

FDA device listing 1949705855 · HongYu BioTech (ShenZhen) Co., Ltd

Key facts

Proprietary names Non-woven Tape; non-woven surgical tape; PE Tape; transparent surgical tape; I.V Dressing; Silicone Tape,Surgical Tape; Foam Tape PVC; Elastic Bandages; Athletic Tape; Bandage
Owner/operator HongYu BioTech (ShenZhen) Co., Ltd
Owner/operator number 10079513
Product codes KGX
Device names KGX - Tape And Bandage, Adhesive
Device class Class I
Classification regulations (21 CFR) 880.5240
Review panels General Hospital
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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