FDA device listing

FACE MASK

FDA device listing 1955087156 · Changzhou DSB Medical Co., Ltd

Key facts

Proprietary names FACE MASK
Owner/operator Changzhou DSB Medical Co., Ltd
Owner/operator number 10035099
Product codes FXX
Device names FXX - Mask, Surgical
Device class Class II
Classification regulations (21 CFR) 878.4040
Review panels General & Plastic Surgery
Registered establishments CHANGZHOU DSB MEDICAL CO., LTD
Establishment registrations 3008850249
FEI numbers 3008850249
Establishment operations Contract 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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