FDA device listing

(Oral Dressing):15g, 30g, 60g, 80g, 90g, 100g, 110g, 120g, 130g, 140g per bottle

FDA device listing 1386358915 · Guang Xi FuLaiMing Biopharmaceutics Co., Ltd.

Key facts

Proprietary names (Oral Dressing):15g, 30g, 60g, 80g, 90g, 100g, 110g, 120g, 130g, 140g per bottle
Owner/operator Guang Xi FuLaiMing Biopharmaceutics Co., Ltd.
Owner/operator number 10093515
Product codes JEW
Device names JEW - Tip, Rubber, Oral Hygiene
Device class Class I
Classification regulations (21 CFR) 872.6650
Review panels Dental
Registered establishments GUANG XI FULAIMING BIOPHARMACEUTICS CO., LTD.
Establishment registrations 3038624837
FEI numbers 3038624837
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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