“The EU applies the CE Marking process primarily to ensure safety, as well as a reinforced manufacturer obligation with respect to device claims. The FDA does this too, but has the additional ...
IRVINE, Calif.--(BUSINESS WIRE)--Telesair, Inc., an innovator of next generation respiratory technology, announced today that it has received CE (Conformité Européenne) Marking under the European ...
FIELD is the first and only truly objective perimeter FDA 510(k) cleared to assess visual field abnormalitiesIrvine, ...
Cerus’ Notified Body, TÜV-SÜD, has completed the review of the clinical module for the CE Mark submission for INTERCEPT Red Blood Cells (RBCs) CONCORD, Calif., July 02, 2025--(BUSINESS WIRE)--Cerus ...
Femasys Inc. announced the achievement of CE mark certification for the FemBloc delivery system, marking it as the first regulatory approval in the world for a non-surgical permanent birth control ...
Beam Global announced that its products, including EV ARC™, BeamBike™, BeamWell™, and BeamPatrol™, have received the CE mark, which signifies compliance with European Union health, safety, and ...
In another boost to its diabetes portfolio, Medtronic plc was granted CE mark approval for its Simplera continuous glucose monitor (CGM) sensor. The EU greenlight for Simplera follows the U.S. FDA ...
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