Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3039487170

FEI Number

3039487170

Entity Name

HELIO DIAGNOSTICS SAS

City/State/Country

Marseille Bouches-du-Rhone, FR

Establishment Address

163 avenue de Luminy, Marseille Bouches-du-Rhone 13009, FR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Helio Diagnostics SAS (Owner Number: 10093994)

Owner / Operator Contact Address

163 avenue de Luminy, Marseille, FR-13 13009, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Prosigna Breast Cancer Assay

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NYI	Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer	Immunology	Class 2	866.6040	2025-09-17

Official Correspondent

Fabienne Hermitte

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@UL.com Phone: (512) 3279997

Related Public Records

Same Entity

Helio Diagnostics SAS

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 3039487170. Last updated year: 2026. Please use registration number 3039487170 when referencing this establishment in official correspondence.