EU → North America Device Access

Accuratus AG

CH-MF-000018336 · Switzerland · Bern

Accuratus AG is registered in the European database on medical devices as a manufacturer, with 379 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa379

Most frequent device types declared: 04.88.53, 04.90.95, 09.07.18, 09.51.16, 09.99.10.

Among these devices, 2 are declared sterile, 379 reusable, 8 active.

Authorised representative in the Union: Accuratus UG.

Devices declared under this manufacturer

Showing 12 of 379 declared devices.

Catalogue references include 04.90.95, 09.07.18, 09.51.16, 09.99.10, 24.06.04, 24.50.01.

European nomenclature codes declared: L0399, L0902, L031399, L0915, L0901, L091302.

United States market access

FDA establishment registerRegistered with FDA
Matched entryACCURATUS AG (CH) · FDA 3012445569
Devices in EUDAMED379
Country of registrationSwitzerland

Device-level evidence

Devices with a numeric GTIN379
Found in the U.S. device database69
Share18.2 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: United States only. Accuratus AG is registered in the United States but was not found in the Canadian register.

Notified body certificates

CertificateStatusExpiry
D1520400003issued2030-11-06

Other manufacturers in Switzerland

All Switzerland manufacturers →