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www.fdanews.com/articles/206855-france-suspends-sale-of-microval-devices-for-lack-of-ce-mark

France Suspends Sale of MicroVal Devices for Lack of CE Mark

March 7, 2022

France's National Medicines Safety Agency has suspended the marketing of several MicroVal devices for lack of a CE mark.

The implants are used to treat female urinary incontinence and hernia of the pelvic organs in women. The affected products are branded as Safire, Swift-Sling, Smile, Prolafix, Procur, S-Swift and Gyne-Pro.

The agency said the suspension will remain in effect until the manufacturer brings the devices back into compliance.

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