Data / Medical devices / France / Stephanix

Stephanix: FDA-registered device maker in La Ricamarie Auvergne-Rhone-Alpes, France, 2 510(k) clearances

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

Stephanix is registered with the FDA (registration 3006972752) in La Ricamarie Auvergne-Rhone-Alpes, France. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 7, 2022. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006972752
Address: 10 Rue Jean Moulin, La Ricamarie Auvergne-Rhone-Alpes, France, 42150
Owner or operator: SEDECAL S.A. (9039772)
Roles: Manufacturer
First device listed: December 24, 2021
Registered through: 2026
Brand names listed: D2RS, D2RS9090, D2RS_9090_AT_PA, D2RS_9090_AT_PA_NV2, D2RS_9090_B1_N, D2RS_9090_B1_NV2, D2RS_AT_PA, D2RS_AT_PA_NV2 and more

Devices it lists

Device	Product code	Class	Role	Source
Interventional Fluoroscopic X-Ray System	OWB	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Angiographic	IZI	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	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
June 7, 2022	K221335	D²RS and D²RS 9090	OWB	Substantially Equivalent	Stephanix	accessdata.fda.gov
December 23, 2021	K213479	D²RS and D²RS 9090	OWB	Substantially Equivalent	Stephanix	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
November 2, 2018	81582	Class II	Terminated	STEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-tracking/images/trash.png Product The D2RS Digital Dynamic Remote System is indicated for use in generating fluoroscopic images of human anatomy for	The firm has detected a potential risk using the command. After releasing the command, the movement of the table may continue instead of stopping.	accessdata.fda.gov

Compare with other makers

Updated June 7, 2022. 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.