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Emano Metrics, Inc.

United Statesfrom the FDA registration address FDA establishment FEI 3021350028

Devices
1
Registrations
FDA
FDA recalls
11 ongoing

Catalogue1

Newest first, rows 1-1 of 1

  • Emano Flow

    None Registry: GUDID Class:II

Company details

FDA FEI number
3021350028
Address
132 E Broadway Suite 700, Eugene, OR, 97401

FDA recalls1

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 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 1
  • 2026

    • 29 May 2026 Z-2777-2026 Class II Ongoing Problem description/Reason for recall: During the period March 22, 2026, to May 29, 2026, recorded urination audio was captured at 48,000 Hz while the model was trained and validated on 44,100 Hz audio. The models depend on the sampling so every recording in the window was therefore processed against a time/frequency scale the models did not expect, producing systematically biased Qmax, Qmean, and voided-volume estimates. The problem usually over-reports flow rate and volume; the firm have made corrected results available to care teams. Distribution: U.S. Nationwide distribution in the states of AR, AZ, CA, CO, FL. IA, ID, NC, NJ, PA, TX and WI.

Frequently asked questions

How many devices does Emano Metrics, Inc. have in the registry?

The registry currently lists 1 device for Emano Metrics, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Emano Metrics, Inc.'s devices?

Among its 1 most recently registered device, Emano Metrics, Inc. has devices listed in FDA GUDID (1 device).

What risk classes do Emano Metrics, Inc.'s devices fall under?

Among its 1 most recently registered device, the classes recorded for Emano Metrics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Emano Metrics, Inc.?

FDA recall records list 1 recall initiated by Emano Metrics, Inc., the most recent initiated on 29 May 2026. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Emano Metrics, Inc. in the registry?

The most recently registered devices listed for Emano Metrics, Inc. include Emano Flow.

Generated automatically from registry data and not verified by a human reviewer.

This is an FDA establishment record. No EUDAMED registration is known for this company.