EU → US Device Access

SYNERGIE INGENIERIE MEDICALE

FR-MF-000001635 · France · Chamberet

SYNERGIE INGENIERIE MEDICALE is registered in the European database on medical devices as a manufacturer, with 185 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class I131
Class IIa41
Class IIb13

Most frequent device types declared: Plastic puncture cannula Ø3.0 x 150mm, Metallic puncture cannula Ø3.0 x 150mm, Balloon 15mm, Metallic puncture cannula Ø2.4 x 100mm, Plastic puncture cannula Ø2.4 x 100mm.

Among these devices, 176 are declared sterile, 144 implantable, 9 reusable, 1 active.

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 registerNot found in the FDA register
Devices in EUDAMED185
Country of registrationFrance
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Notified body certificates

CertificateStatusExpiry
2026 CR 0075issued2031-02-16

Other manufacturers in France

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