FDA device listing

Disposable Tourniquet Cuff; Single Use Tourniquet Cuff; Pneumatic Tourniquet; Reusable Tourniquet Cuff;,Tourniquet Cuff…

FDA device listing 1470544019 · Tiantai Shengtengyun Medical Supplies Co., Ltd

Key facts

Proprietary names Disposable Tourniquet Cuff; Single Use Tourniquet Cuff; Pneumatic Tourniquet; Reusable Tourniquet Cuff;,Tourniquet Cuff; Cuff; Medical Tourniquet Cuff
Owner/operator Tiantai Shengtengyun Medical Supplies Co., Ltd
Owner/operator number 10043944
Product codes KCY
Device names KCY - Tourniquet, Pneumatic
Device class Class I
Classification regulations (21 CFR) 878.5910
Review panels General & Plastic Surgery
Registered establishments Tiantai Shengtengyun Medical Supplies Co., Ltd.
Establishment registrations 3010410654
FEI numbers 3010410654
Establishment operations Contract Manufacturer, Foreign Exporter, 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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