EU → North America Device Access

APIS Technologies

CH-MF-000039694 · Switzerland · Geneva

APIS Technologies is registered in the European database on medical devices as a manufacturer, with 20 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb19
Class I1

Most frequent device types declared: IS-1, IS-10, IS-13, IS-5, IS-6.

Among these devices, 20 are declared sterile, 20 implantable.

Authorised representative in the Union: DiLo Medical.

Devices declared under this manufacturer

Showing 12 of 20 declared devices.

Catalogue references include IS-1, IS-10, IS-13, IS-5, IS-6, IS-M-1.

European nomenclature codes declared: U070101, P900202.

United States market access

FDA establishment registerRegistered with FDA
Matched entryAPIS Technologies Sarl (CH) · FDA 3017791709
Devices in EUDAMED20
Country of registrationSwitzerland

Device-level evidence

Devices with a numeric GTIN20
Found in the U.S. device database6
Share30.0 %

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. APIS Technologies is registered in the United States but was not found in the Canadian register.

Other manufacturers in Switzerland

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