FDA device listing

Bodystat MultiScan 5000

FDA device listing 1545162527 · BodyStat Ltd

Key facts

Proprietary names Bodystat MultiScan 5000
Owner/operator BodyStat Ltd
Owner/operator number 10024885
Premarket submissions K971554
Product codes MNW
Device names MNW - Analyzer, Body Composition
Device class Class II
Classification regulations (21 CFR) 870.2770
Review panels Cardiovascular
Registered establishments BODYSTAT LTD
Establishment registrations 3006948217
FEI numbers 3006948217
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1–9 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes 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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