EU → US Device Access

HYPHEN BioMed

FR-MF-000002214 · France · Neuville-sur-Oise

HYPHEN BioMed is registered in the European database on medical devices as a manufacturer, with 65 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

other65

Most frequent device types declared: LMWH Control, Factor Xa (FXa) inhibitors, Antithrombin (AT) activity - AntiXa, UFH Control, Control Plasma.

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 entryHYPHEN BIOMED SASU (FR) · FDA 3004434070
Devices in EUDAMED65
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
HX 1348148-1amended2027-12-14

Other manufacturers in France

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