EU → US Device Access

Biosensors Europe SA

CH-MF-000015764 · Switzerland · Morges

Biosensors Europe SA is registered in the European database on medical devices as a manufacturer, with 223 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class I223

Most frequent device types declared: BMX6-2209, BFR1-2728, NCB-22512, NCB-40020, BFC1-2224.

Among these devices, 223 are declared sterile, 166 implantable.

Authorised representative in the Union: DE-AR-000006441.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED223
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
TD745.151issued2031-03-12
745.151issued2031-03-12

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