Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013530341

FEI Number

3013530341

Entity Name

Voluntis

City/State/Country

Rueil-Malmaison Hauts-de-Seine, FR

Establishment Address

12-14 Rue Louis Bleriot, Rueil-Malmaison Hauts-de-Seine 92500, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Voluntis (Owner Number: 10053592)

Owner / Operator Contact Address

58 avenue de Wagram, Paris, FR-75 75017, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K170669

PMA Number

N/A

All Registered Proprietary Names

Insulia Diabetes Management Companion Insulia Diabetes Management Companion

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NDC	Calculator, Drug Dose	Anesthesiology	Class 2	868.1890	2016-12-20
NDC	Calculator, Drug Dose	Anesthesiology	Class 2	868.1890	2017-08-07

Official Correspondent

Raffi Krikorian

US Agent Details

Kevin Howard Business: Aptar Digital Health Email: kevin.howard@aptar.com Phone: (617) 2454119

Related Public Records

Same Entity

Voluntis

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013530341. Last updated year: 2026. Please use registration number 3013530341 when referencing this establishment in official correspondence.