Data / Medical devices / France / 3-D Matrix Europe SAS

3-D Matrix Europe SAS: FDA-registered device maker in Caluire et Cuire Rhone, France, 8 510(k) clearances

Name: 3-D Matrix Europe SAS FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

3-D Matrix Europe SAS is registered with the FDA (registration 3012263097) in Caluire et Cuire Rhone, France. It lists 5 device types. The FDA files 8 510(k) clearances under its listings, the newest dated August 3, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012263097
Address: 11 chemin des Petites Brosses 2nd Floor, Caluire et Cuire Rhone, France, 69300
Owner or operator: 3-D MATRIX EUROPE SAS (10084567)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: March 7, 2022
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic	MGQ	U	Specification developer	accessdata.fda.gov
Hemostatic Device For Endoscopic Gastrointestinal Use	QAU	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Oral Wound Dressing	OLR	U	Specification developer	accessdata.fda.gov
Polymer, Ear, Nose And Throat, Synthetic, Absorbable	NHB	2	Specification developer	accessdata.fda.gov
Protective Coating, Mucoadhesive Application, For The Rectal Mucosa	PHN	U	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 3, 2026	K261504	PuraStat-RM	PHN	Substantially Equivalent	3-D Matrix, Inc.	accessdata.fda.gov
August 3, 2026	K261503	PuraStat GI	QAU	Substantially Equivalent	3-D Matrix, Inc.	accessdata.fda.gov
January 7, 2026	K253924	PuraStat	QAU	Substantially Equivalent	3-D Matrix Europe SAS	accessdata.fda.gov
January 7, 2026	K253923	PuraStat	PHN	Substantially Equivalent	3-D Matrix Europe SAS	accessdata.fda.gov
February 28, 2023	K222481	PuraStat	QAU	Substantially Equivalent	3-D Matrix, Inc.	accessdata.fda.gov
April 1, 2022	K213552	PuraStat-RM	PHN	Substantially Equivalent	3-D Matrix, Inc.	accessdata.fda.gov
October 8, 2021	K210211	PuraStat-OM	OLR	Substantially Equivalent	3-D Matrix, Inc.	accessdata.fda.gov
April 12, 2019	K183015	PuraSinus	NHB	Substantially Equivalent	3-D Matrix, Inc.	accessdata.fda.gov

Compare with other makers

Updated August 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.