Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021453307

FEI Number

3021453307

Entity Name

TISSIUM SA

City/State/Country

Paris 12e Arrondissement, FR

Establishment Address

74 Rue Du Faubourg Saint-Antoine, Paris 12e Arrondissement 75012, FR

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

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

DEN240066

PMA Number

N/A

All Registered Proprietary Names

COAPTIUM Selector TISSIUM LIGHT COAPTIUM Connect

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
SFD	In Situ Polymerizing Peripheral Nerve Repair Device	Neurology	Class 2	882.5270	2025-07-09

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
3015546200	TISSIUM SA	Roncq Nord, FR

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021453307. Last updated year: 2026. Please use registration number 3021453307 when referencing this establishment in official correspondence.