EU → US Device Access

Haemonetics S.A.

CH-MF-000034549 · Switzerland · Signy-Centre

Haemonetics S.A. is registered in the European database on medical devices as a manufacturer, with 32 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb27
Class IIa5

Most frequent device types declared: Plasma Collection Sets with BMB bowl, Plasma Collection Sets with HS bowl, PLT & PLS SET W/FILTER, Plasma Harness Sets, PLT&RBC Set w/PLT&RBC Filter.

Among these devices, 32 are declared sterile.

Authorised representative in the Union: IT-AR-000021067.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED32
Country of registrationSwitzerland
⚠️ 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
G15 071750 0032restricted2030-10-08

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