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Bionen S.A.S.

Country not established

Devices
1

What Bionen S.A.S. makes

Bionen S.A.S. manufactures concentric and monopolar needles designed for both single-use and reusable applications, primarily intended for medical procedures requiring precise tissue penetration.

These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.

AI-generated from registry data, 19 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1

Newest first, rows 1-1 of 1

Frequently asked questions

How many devices does Bionen S.A.S. have in the registry?

The registry currently lists 1 device for Bionen S.A.S.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Bionen S.A.S.'s devices?

Among its 1 most recently registered device, Bionen S.A.S. has devices listed in FDA 510(k) (1 device).

What risk classes do Bionen S.A.S.'s devices fall under?

Among its 1 most recently registered device, the classes recorded for Bionen S.A.S.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Bionen S.A.S. in the registry?

The most recently registered devices listed for Bionen S.A.S. include DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE.

Generated automatically from registry data and not verified by a human reviewer.