FDA device listing

Non-woven Cap

FDA device listing 1080798690 · Heaven Healthcare Co., Ltd.

Key facts

Proprietary names Non-woven Cap
Owner/operator Heaven Healthcare Co., Ltd.
Owner/operator number 10050953
Product codes FYF
Device names FYF - Cap, Surgical
Device class Class I
Classification regulations (21 CFR) 878.4040
Review panels General & Plastic Surgery
Registered establishments Heaven Healthcare Co., Ltd.
Establishment registrations 3012034017
FEI numbers 3012034017
Establishment operations 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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