EU → US Device Access

Novastep S.A.S.

FR-MF-000002428 · France · RENNES

Novastep S.A.S. is registered in the European database on medical devices as a manufacturer, with 354 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIb228
Class IIa126

Among these devices, 238 are declared sterile, 228 implantable, 77 reusable.

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 registerSimilar name found — unverified
Matched entryNOVASTEP (FR) · FDA 3010673777
Devices in EUDAMED354
Country of registrationFrance
⚠️ A similar name exists in the FDA register. We do not assert that it is the same company — the two registers share no common identifier, and a name alone is not proof. This entry needs a human check.

Notified body certificates

CertificateStatusExpiry
FR24/00000077supplemented2029-03-21

Other manufacturers in France

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