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Data / Medical devices / Israel / Fairtility Ltd.

Fairtility Ltd.: FDA-registered device maker in Tel Aviv, Israel, 1 510(k) clearance

Fairtility Ltd. is registered with the FDA (registration 3042972064) in Tel Aviv, Israel. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 15, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3042972064
Address
2 Hashlosha St. Edgar 360, building C, entrance D Brain Embassy, 17th floor, Office No. 5, Tel Aviv, Israel, 6706062
Owner or operator
Fairtility Ltd. (10094755)
Roles
Manufacturer
First device listed
December 21, 2025
Registered through
2026
Brand names listed
CHLOE BLAST

Devices it lists

DeviceProduct codeClassRoleSource
Embryo Image Assessment System, Assisted ReproductionPBH2Manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 15, 2025K243851CHLOE BLASTPBHSubstantially EquivalentFairtility , Ltd.accessdata.fda.gov

Compare with other makers

Updated August 15, 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.