FDA device listing

Accessory, Surgical Apparel

FDA device listing 1633089102 · Zhangjiagang Shengang Medical Products Co.,Ltd

Key facts

Owner/operator Zhangjiagang Shengang Medical Products Co.,Ltd
Owner/operator number 10063070
Product codes LYU
Device names LYU - Accessory, Surgical Apparel
Device class Class I
Classification regulations (21 CFR) 878.4040
Review panels General & Plastic Surgery
Registered establishments ZHANGJIAGANG SHENGANG MEDICAL PRODUCTS CO.,LTD
Establishment registrations 3016616327
FEI numbers 3016616327
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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