EU → US Device Access

Newclip Technics SAS

FR-MF-000011809 · France · Haute Goulaine

Newclip Technics SAS is registered in the European database on medical devices as a manufacturer, with 4 876 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb3 800
Class IIa1 076

Among these devices, 2 119 are declared sterile, 3 800 implantable, 961 reusable, 406 with a measuring function.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerRegistered with FDA
Matched entryNEWCLIP TECHNICS SAS (FR) · FDA 3007143290
Devices in EUDAMED4 876
Country of registrationFrance

Notified body certificates

CertificateStatusExpiry
FR22/00000038supplemented2027-09-13

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