EU → US Device Access

B.Well Swiss AG

CH-MF-000012588 · Switzerland · Widnau

B.Well Swiss AG is registered in the European database on medical devices as a manufacturer, with 54 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa54

Most frequent device types declared: WT-03, WT-04, WT-06, PRO-03, PRO-04, PRO-05, PRO-06, WS-1, WS-2, WS-3, MED-120, PRO-110, PRO-115, TH-130, MED-111, MED-130, PRO-100, PRO-101, WF-4000, WF-5000, MED-3000, TH-7000, PRO-30.

Among these devices, 44 are declared active, 40 with a measuring function.

Authorised representative in the Union: LI-AR-000000233.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED54
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
44911220852supplemented2029-11-12

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