EU → US Device Access

FKG Dentaire Sàrl

CH-MF-000017925 · Switzerland · Le Crêt-du-Locle

FKG Dentaire Sàrl is registered in the European database on medical devices as a manufacturer, with 1 168 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa1 168

Most frequent device types declared: S1.7B0.00.0FI.FK, 01.7B0.00.0EO.FK, 03.050.31.025.CT, S1.XB0.00.0BD.FK, 02.171.25.030.GM.

Among these devices, 565 are declared sterile, 673 reusable.

Authorised representative in the Union: NL-AR-000000116.

United States market access

FDA establishment registerSimilar name found — unverified
Matched entryFKG DENTAIRE SARL (CH) · FDA 9680913
Devices in EUDAMED1 168
Country of registrationSwitzerland
⚠️ 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
CH24/00000083supplemented2029-09-27

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