FDA device listing

baby blanket; stretcher sheets

FDA device listing 1497065734 · Jiangsu Guangda Medical Material Group Co., Ltd.

Key facts

Proprietary names baby blanket; stretcher sheets
Owner/operator Jiangsu Guangda Medical Material Group Co., Ltd.
Owner/operator number 10023676
Product codes KME
Device names KME - Bedding, Disposable, Medical
Device class Class I
Classification regulations (21 CFR) 880.6060
Review panels General Hospital
Registered establishments Jiangsu Guangda Medical Material Group Co., Ltd.
Establishment registrations 3006847952
FEI numbers 3006847952
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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