EU → US Device Access

Luciole Medical AG

CH-MF-000015856 · Switzerland · Zurich (ZH)

Luciole Medical AG is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa8
Class I1

Most frequent device types declared: 20020.

Among these devices, 1 are declared sterile, 1 active, 2 with a measuring function.

Authorised representative in the Union: DE-AR-000005578.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED9
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
7229GB448240322issued2027-07-15
13560GB450240322issued2029-03-21

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