Data / Medical devices / Israel / Rimed Ltd

Rimed Ltd: FDA-registered device maker in RAANANA Central, Israel, 3 510(k) clearances

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

Rimed Ltd is registered with the FDA (registration 9616774) in RAANANA Central, Israel. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 10, 2017. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9616774
FEI number: 3002494651
Address: 25 Hacharoshet Street Industrial Park Raanana, RAANANA Central, Israel, 4365613
Owner or operator: RIMED LTD. (9032412)
Roles: Manufacturer, Repackager or relabeler
First device listed: March 30, 2008
Registered through: 2026
Brand names listed: DIGI-LITE, DIGI-LITE 2, Digi-Lite IP+, Digi-One, SmartUs EXT-1M/3M

Devices it lists

Device	Product code	Class	Role	Source
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Repackager or relabeler	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Manufacturer, Repackager or relabeler	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 10, 2017	K163121	SmartUs EXT-1M/3M	IYN	Substantially Equivalent	Telemed	accessdata.fda.gov
June 23, 2015	K143476	Digi-One	IYN	Substantially Equivalent	Rimed , Ltd.	accessdata.fda.gov
September 18, 2006	K062578	DIGI-LITE TCD DEVICE	IYN	Substantially Equivalent	Rimed , Ltd.	accessdata.fda.gov

Compare with other makers

Updated August 10, 2017. 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.