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Eitan Medical

Eitan Medical wins EU clearance for Sapphire infusion pump

March 10, 2021 By Sean Whooley

Eitan Medical

Eitan Medical announced that it received European Union Medical Device Recognition (MDR) certification for its Sapphire infusion pump. Approval for the Sapphire infusion pump, along with its accessories and administration sets, was granted in January 2021, according to a news release. The certification is EU MDR 2017/45. Sapphire includes upgraded Rev15 software, also EU MDR […]

Filed Under: Drug-Device Combinations, Featured, Regulatory/Compliance Tagged With: Eitan Medical

Eitan Medical lands FDA clearance for infusion pump system upgrade

January 19, 2021 By Nancy Crotti

Eitan Medical

Eitan Medical (formerly Eitan Group) announced today that the FDA has granted 510(k) clearance to its upgraded Sapphire infusion pump system software Rev15, which includes the infusion pump, administration sets and accessories. The Sapphire infusion system is the company’s flagship infusion device and is used across the U.S. within alternate sites, homecare markets, emergency medical […]

Filed Under: Featured, Food & Drug Administration (FDA) Tagged With: Eitan Medical, FDA

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