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EchoNous

Active in EUDAMED
Also registered as EchoNous, Inc.

United Statesfrom SRN EUDAMED FDA SRN US-MF-000004161 FEI 3013757696

EchoNous is a medical device manufacturer based in the United States, with 77 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II and I; EU Class IIa and I) and 1 FDA recall as of 13 Nov 2026.

Devices
77
Registrations
EUDAMEDFDA
FDA recalls
11 ongoing

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 58
  • EUDAMED 37
  • FDA 510(k) 5

A device listed in two registries counts in both.

Device classes
  • FDA Class II 39
  • EU Class IIa 31
  • EU Class I 6
  • FDA Class I 1
Top EMDN categories
FDA recalls
Sites and related companies
Identifiers
  • EUDAMED SRN US-MF-000004161
  • FDA FEI 3013757696

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate
United States
FDA FEI, FDA recalls
Authorised rep.
Advena LimitedMT

Catalogue77

Newest first, rows 1-50 of 77

Search and filter all 77 devices
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Rows 1-50 of 77

Showing 1-50 of 77

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000004161
FDA FEI number
3013757696
EUDAMED status
Active
EUDAMED registered name
EchoNous
Registered address
8310 154th Ave NE, 98052, Redmond, United States
Website
echonous.com
PRRC contact
Joshua Kim(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 28 Nov 2027

EUDAMED certificates (1)

BSI Group The Netherlands B.V. 2797 1 certificate

  • MDR 726583 Active

    Quality management system EU MDR

    Issued
    29 Nov 2022
    Expires
    28 Nov 2027

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 1
  • 2025 0
  • 2026 0

  • 2024

    • 9 May 2024 Z-2325-2024 Class II Ongoing Ultrasound system has a bug in affected iOS software, which after DICOM export, can cause inaccuracy in postprocessed measurements done in 3rd party software, such as PACS or other post-processing software, which may lead to inaccurate diagnoses or treatment. Distribution: US: ID, TX, WI, KS, IL, GA, MI, CA, OH, FL, AK, UT, MD, NY, NV, CO, ND, WA, DC, LA, KY, MN, HI, NM, TN, NJ, ID, MI, VT,…
      Full distribution text US: ID, TX, WI, KS, IL, GA, MI, CA, OH, FL, AK, UT, MD, NY, NV, CO, ND, WA, DC, LA, KY, MN, HI, NM, TN, NJ, ID, MI, VT, AZ, MO, AL, MA, NC OUS: Denmark, Switzerland, Austria, Italy, France, United Kingdom, Germany, Spain, Romania, Finland, Romania, Australia, India, Hong Kong, Thailand
      Submission number: K212100

Frequently asked questions

How many devices does EchoNous have in the registry?

The registry currently lists 77 devices for EchoNous. Devices recorded under merged duplicate company entries are counted once.

Which registries list EchoNous's devices?

Among its 50 most recently registered devices, EchoNous has devices listed in EUDAMED (15 devices) and FDA GUDID (37 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do EchoNous's devices fall under?

Among its 50 most recently registered devices, the classes recorded for EchoNous's devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for EchoNous?

FDA recall records list 1 recall initiated by EchoNous, the most recent initiated on 9 May 2024. 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 EUDAMED certificates are recorded for EchoNous?

EUDAMED lists 1 certificate for EchoNous (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 29 Nov 2022.

What are the newest devices from EchoNous in the registry?

The most recently registered devices listed for EchoNous include NXT Cable A, Kosmos Torso NXT A, Kosmos Torso NXT A (Refurbished) and Kosmos Torso NXT (Refurbished).

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