Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012263097

FEI Number

3012263097

Entity Name

3-D MATRIX EUROPE SAS

City/State/Country

Caluire et Cuire Rhone, FR

Establishment Address

11 chemin des Petites Brosses, 2nd Floor, Caluire et Cuire Rhone 69300, FR

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

3-D MATRIX EUROPE SAS (Owner Number: 10084567)

Owner / Operator Contact Address

11 chemin des Petites Brosses, 2nd Floor, Caluire et Cuire, FR-69 69300, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K210211

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QAU	Hemostatic Device For Endoscopic Gastrointestinal Use	General, Plastic Surgery	Class 2	878.4456	2026-01-09
NHB	Polymer, Ear, Nose And Throat, Synthetic, Absorbable	Ear, Nose, Throat	Class 2	874.3620	2022-03-07
MGQ	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic	Unknown	Class U	N/A	2025-12-17
OLR	Oral Wound Dressing	Unknown	Class U	N/A	2025-12-17

Official Correspondent

Audrey VION

US Agent Details

Alan Miskewicz Business: 3-D Matrix, Inc. Email: amiskewicz@3dmatrix.com Phone: (781) 3739020

Related Public Records

Same Entity

3-D MATRIX EUROPE SAS

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K954741	Derma Sciences, Inc.	DERMAGRAN WENT DRESSING (DEXTROSE-SALINE)	1995-11-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2025	Wilson-Cook Medical Inc.	2	Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemostat, REF G21049, 3.7 mm, Sterile. The device is used for hemostasis of nonvariceal gastrointestinal bleeding.
Z-0001-05	DeRoyal Wound Care	U	Aquasorb Border, Hydrogel Wound Dressing with Polyurethane Film Border, 25 individual packets per case, Catalog # 46-511, 2.5' x 2.5', labeled in part *SterileManufacturer: DeRoyal 200 Debusk Lane Powell, TN 37849 USA**

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3004681519	Sterigenics Belgium Fleurus SA	Fleurus Hainaut, BE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012263097. Last updated year: 2026. Please use registration number 3012263097 when referencing this establishment in official correspondence.