EU → North America Device Access

INFOMED SA

CH-MF-000021686 · Switzerland · Meinier

INFOMED SA is registered in the European database on medical devices as a manufacturer, with 55 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb8
Class IIa47

Most frequent device types declared: Accessories Class IIa, Accessories class I, DIMI tubing sets, HF440, HF440 tubing sets.

Among these devices, 41 are declared sterile, 3 active.

Authorised representative in the Union: INFOMED SAS.

Devices declared under this manufacturer

Showing 12 of 55 declared devices.

Catalogue references include DF-140-00, DI-100-01, HF-440-05, IN-300-00, LF-050-00, TU-000-80.

European nomenclature codes declared: F020180, B030201, F010604, F020280, F9099, F02020202.

United States market access

FDA establishment registerRegistered with FDA
Matched entryINFOMED SA (CH) · FDA 3014272786
Devices in EUDAMED55
Country of registrationSwitzerland

Device-level evidence

Devices with a numeric GTIN55
Found in the U.S. device database0
Share0.0 %

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. INFOMED SA is registered in the United States but was not found in the Canadian register.

Other manufacturers in Switzerland

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