FDA device listing

HDI-210, HDI-200A, HDI-220D, HDI-220DA, HDI-712C. HDI-712D,Intraroral Camera

FDA device listing 1276622339 · Shanghai Handy Medical Equipment Co., Ltd.

Key facts

Proprietary names HDI-210, HDI-200A, HDI-220D, HDI-220DA, HDI-712C. HDI-712D,Intraroral Camera
Owner/operator Shanghai Handy Medical Equipment Co., Ltd.
Owner/operator number 10054306
Product codes NRD
Device names NRD - Unit, Operative Dental, Accessories
Device class Class I
Classification regulations (21 CFR) 872.6640
Review panels Dental
Registered establishments SHANGHAI HANDY MEDICAL EQUIPMENT CO., LTD.
Establishment registrations 3013039893
FEI numbers 3013039893
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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