EU → North America Device Access

Biodenta Swiss AG

CH-MF-000034374 · Switzerland · Berneck

Biodenta Swiss AG is registered in the European database on medical devices as a manufacturer, with 74 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa69
Class IIb5

Most frequent device types declared: AB-B040GH2A, AB-B040GH2N, CAD-SBBBLB0, CAD-UABBLB0, CS-B0018B2C.

Among these devices, 1 are declared sterile, 5 implantable.

Authorised representative in the Union: MedNet EC-REP IIb GmbH.

Devices declared under this manufacturer

Showing 12 of 74 declared devices.

Catalogue references include AD-UANRRP, CAD-SBBBLB2, CAD-SBNBARP, CAD-SBNBNPI, CAD-SBNBWPI, CAD-UAATOS4550.

European nomenclature codes declared: Q010280, Q010207, P01020180, P01020101.

United States market access

FDA establishment registerRegistered with FDA
Matched entryBIODENTA SWISS AG (CH) · FDA 3008088588
Devices in EUDAMED74
Country of registrationSwitzerland

Device-level evidence

Devices with a numeric GTIN74
Found in the U.S. device database51
Share68.9 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryBIODENTA SWISS AG

North American profile: Both markets. Biodenta Swiss AG is registered in both the United States and Canada.

Other manufacturers in Switzerland

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