Idmed: FDA-registered device maker in Marseille Bouches-du-Rhone, France, 3 510(k) clearances

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

Idmed is registered with the FDA (registration 3012072872) in Marseille Bouches-du-Rhone, France. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 12, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012072872
Address: 3 rue John Maynard Keynes, Marseille Bouches-du-Rhone, France, 13013
Owner or operator: Idmed (10058016)
Roles: Manufacturer
First device listed: June 26, 2018
Registered through: 2026
Brand names listed: CuffGuard, NeuroLight, ToFscan, WiTOF

Devices it lists

Device	Product code	Class	Role	Source
Cuff, Tracheal Tube, Inflatable	BSK	2	Manufacturer	accessdata.fda.gov
Pupillometer, Ac-Powered	HLG	1	Manufacturer	accessdata.fda.gov
Stimulator, Nerve, Peripheral, Electric	KOI	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
August 12, 2025	K243562	CuffGuard	BSK	Substantially Equivalent	Idmed	accessdata.fda.gov
June 23, 2025	K243339	WiTOF	KOI	Substantially Equivalent	Idmed	accessdata.fda.gov
May 31, 2018	K172690	ToFscan	KOI	Substantially Equivalent	Idmed	accessdata.fda.gov

Compare with other makers

Updated August 12, 2025. 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.