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Voluntis

Active in EUDAMED

Francefrom SRN EUDAMED FDA SRN FR-MF-000003043 FEI 3013530341

Part of Voluntis Sa.

Devices
1
Registrations
EUDAMEDFDA
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI, FDA recalls

What Voluntis makes

Voluntis makes the HeroTracker Sense 1.2 and Respi.Me devices.

These devices are classified as Class I and are listed in the Eudamed registry; the company is based in France.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1

Newest first, rows 1-1 of 1

  • LuerVax Ref 01

    Class I
    Active CE MDR EUDAMED I

Company details

EUDAMED SRN
FR-MF-000003043
FDA FEI number
3013530341
DUNS number
572684194
EU VAT number
FR 55 439 685 850
EUDAMED status
Active
EUDAMED registered name
Voluntis
Registered address
58, Avenue de Wagram, 75017, Paris, France
PRRC contact
Raffi Krikorian(public in EUDAMED)

FDA recalls1

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

FDA recall records list 1 recall initiated by Voluntis, initiated on 2018-10-08. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

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

  • 2018

    • 8 Oct 2018 Z-0478-2019 Class II Terminated The firm identified an issue with the basal calculator identified on the Android version of the Insulia application. The bug could lead from low-impact to high-impact hypoglycemia depending on the circumstances. A new update of Insulia is now available (version 1.6.42), which resolves this issue. Distribution: Distributed to accounts in Arizona, Masachusetts, Michigan, Ohio, Tennessee, and Vermont. International distribution to…
      Full distribution text Distributed to accounts in Arizona, Masachusetts, Michigan, Ohio, Tennessee, and Vermont. International distribution to Canada and France (however, French customers are not affected by this recall).
      Submission numbers: K170669, K172177

Frequently asked questions

How many devices does Voluntis have in the registry?

The registry currently lists 1 device for Voluntis. Devices recorded under merged duplicate company entries are counted once.

Which registries list Voluntis's devices?

Among its 1 most recently registered device, Voluntis has devices listed in EUDAMED (1 device).

What risk classes do Voluntis's devices fall under?

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

Are there FDA recall records for Voluntis?

FDA recall records list 1 recall initiated by Voluntis, the most recent initiated on 2018-10-08. 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 Voluntis in the registry?

The most recently registered devices listed for Voluntis include LuerVax.

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