Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009523773

FEI Number

3009523773

Entity Name

FIRALIS S.A.

City/State/Country

Huningue Haut-Rhin, FR

Establishment Address

35, rue du Fort, Huningue Haut-Rhin 68330, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

FIRALIS S.A. (Owner Number: 10093823)

Owner / Operator Contact Address

35, rue du Fort, Huningue, FR-68 68330, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN240032

PMA Number

N/A

All Registered Proprietary Names

APO-Easy® genotyping kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
SFC	Neurologic Disease Risk Assessment Molecular Test	Immunology	Class 2	866.5850	2025-07-16

Official Correspondent

Hueseyin Firat

US Agent Details

Sidzigui Christelle OUEDRAOGO Business: FMP Inc. Email: christelle.ouedraogo@firalis.com Phone: (857) 3397478

Related Public Records

Same Entity

FIRALIS S.A.

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3028606342	OMAY(GUANGZHOU) MED TECHNOLOGIES CO., LTD	Guangzhou Guangdong, CN
3038274470	BRAINMATTERZ, INC	McKinney, TX, US
3012404174	LABORATORIO CHIMICO FARMACEUTICO A. SELLA SRL.	Schio Vicenza, IT
3042364673	NEURALYTIX LLC	Fruita, CO, US
3043617526	AD SCIENTIAM	Paris Ile-de-France, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009523773. Last updated year: 2026. Please use registration number 3009523773 when referencing this establishment in official correspondence.