Facility

Impedimed Limited

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3004782476
Establishment type	Manufacture Medical Device
Location	Suite 31C, 12-18 Tryon Rd. Lindfield New South Wales, AU 2070
Registration status	Active · expires 2026
Parent company	Impedimed Limited (owner-operator 10023581)
Brand names	L-Dex U400

Activity by year

Recalls (1)

Devices registered here (1)

Monitor, Extracellular Fluid, Lymphedema, Extremity
Product code OBH (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.2770

Recalls & enforcement

Class IIOngoing2023-08-17
Bilateral L-Dex assessment software does not have the same level of sensitivity to help detect early signs of lymphedema as the unilateral arm L-Dex assessment, which could result in under-recognition of early lymphedema, which could result in delay in early intervention, and mor…

All facilities operated by Impedimed Limited

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Impedimed Limited (FEI 3004782476) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004782476-impedimed-limited/

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