FDA device listing

Amazfit Balance A2287

FDA device listing 1494717649 · Anhui Huami Information Technology Co., Ltd.

Key facts

Proprietary names Amazfit Balance A2287
Owner/operator Anhui Huami Information Technology Co., Ltd.
Owner/operator number 10083608
Product codes PUH
Device names PUH - Analyzer, Body Composition, Exempt
Device class Class II
Classification regulations (21 CFR) 870.2770
Review panels Cardiovascular
Registered establishments ANHUI HUAMI INFORMATION TECHNOLOGY CO., LTD.
Establishment registrations 3003884252
FEI numbers 3003884252
Establishment operations Foreign Exporter, Manufacturer, Specification Developer
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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