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Echosens Creteil: FDA-registered device maker in Creteil Val-de-Marne, France, 6 510(k) clearances

Name: Echosens Creteil FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Echosens Creteil is registered with the FDA (registration 3012038665) in Creteil Val-de-Marne, France. It lists 2 device types. The FDA files 6 510(k) clearances under its listings, the newest dated July 30, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012038665
Address: 5 Rue Jean Lemoine, Creteil Val-de-Marne, France, 94000
Owner or operator: Echosens (10043955)
Roles: Manufacturer
First device listed: September 7, 2015
Registered through: 2026
Brand names listed: FibroScan 230, FibroScan 430 Mini+, FibroScan 630, FibroScan S+ probe, FibroScan® S+ probe, Fibroscan 530 Compact

Devices it lists

Device	Product code	Class	Role	Source
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Manufacturer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Manufacturer	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
July 30, 2021	K212035	FibroScan 230	IYO	Substantially Equivalent	Echosens	accessdata.fda.gov
July 16, 2020	K200655	FibroScan® 630	IYO	Substantially Equivalent	Echosens	accessdata.fda.gov
July 9, 2018	K181547	FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)	IYO	Substantially Equivalent	Echosens	accessdata.fda.gov
September 13, 2017	K172142	FibroScan 430 Mini+	IYO	Substantially Equivalent	Echosens	accessdata.fda.gov
March 18, 2016	K160524	FibroScan 530 Compact	IYO	Substantially Equivalent	Echosens	accessdata.fda.gov
September 1, 2015	K150239	FibroScan	IYO	Substantially Equivalent	Echosens	accessdata.fda.gov

Compare with other makers

Updated July 30, 2021. 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.