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Empowered Diagnostics LLC

Active in EUDAMED

United Statesfrom EUDAMED address EUDAMED SRN US-MF-000008154

Devices
0
Registrations
EUDAMED
FDA recalls
2

No devices from this company are in the catalogue yet.

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA recalls

Company details

EUDAMED SRN
US-MF-000008154
EUDAMED status
Active
EUDAMED registered name
EMPOWERED DIAGNOSTICS LLC
EUDAMED abbreviated name
EMPOWERED DIAGNOSTICS
Website
www.empdx.net This website had an invalid or expired security certificate when we last checked. Last checked 18 Oct 2026.
Phone
+19543542768
PRRC contact
Silvia Valik(public in EUDAMED)

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 2
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

  • 2021

    • 22 Dec 2021 Z-0480-2022 Class I Completed COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA. Distribution: US Nationwide Distribution
    • 22 Dec 2021 Z-0481-2022 Class I Completed COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA. Distribution: US Nationwide Distribution