Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015546200

FEI Number

3015546200

Entity Name

TISSIUM SA

City/State/Country

Roncq Nord, FR

Establishment Address

TISSIUM F1 Manufacturing Site, Parc Activite Pierre Mauroy, 2 rue Pierre Antoine Delahousse, Roncq Nord 59223, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TISSIUM (Owner Number: 10093777)

Owner / Operator Contact Address

74 rue du Faubourg Saint-Antoine, Paris, FR-IDF 75012, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

COAPTIUM Selector

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2025-09-30

Official Correspondent

Clara Defraye

US Agent Details

Marie-Astrid SEVILLA Email: masevilla@tissium.com Phone: (857) 5002255

Related Public Records

Same Entity

TISSIUM

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3021453307	TISSIUM SA	Paris 12e Arrondissement, FR

Similar Registrations

Registration Number	Establishment Name	Location
3026820968	NEURGAIN TECHNOLOGIES	La Jolla, CA, US
3006247277	OPTICO LTD	LETCHWORTH Hertfordshire, GB
3005621335	DEVEMED GMBH	NEUHAUSEN OB ECK Baden-Wurttemberg, DE
2126670	SCANLAN INTERNATIONAL, INC.	Saint Paul, MN, US
3012833053	PATHWAY MEDTECH, LLC.	Santee, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015546200. Last updated year: 2026. Please use registration number 3015546200 when referencing this establishment in official correspondence.