# HELIO DIAGNOSTICS SAS

FEI: 3039487170
Status: Active
Establishment types: Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner/operator: Helio Diagnostics SAS (#10093994)

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

Mandatory US Agent: Emergo Global Representation LLC

## Products

Total registered: 1
Top product codes: NYI
Regulation §: 866.6040

Proprietary names: Prosigna Breast Cancer Assay

## Source

- openFDA: https://api.fda.gov/device/registrationlisting.json?search=registration.fei_number:%223039487170%22
- FDA Registration Lookup: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=3039487170