EU → North America Device Access

Assut Medical Sàrl

CH-MF-000009358 · Switzerland · Pully

Assut Medical Sàrl is registered in the European database on medical devices as a manufacturer, with 4 341 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class I4 274
Class IIb35
Class IIa32

Most frequent device types declared: Sterile metallic non-absorbable surgical suture material, Sterile non-absorbable pledgets pre-punched, Sterile non-absorbable surgical suture material, Sterile synthetic absorbable surgical suture material, Sterile synthetic non-absorbable surgical suture material.

Among these devices, 4 341 are declared sterile, 1 880 implantable.

Authorised representative in the Union: Medical Technology Promedt Consulting GmbH.

Devices declared under this manufacturer

Showing 12 of 4 341 declared devices.

Catalogue references include 136, 3586, 4607, 60039, 645F, 9563.

European nomenclature codes declared: H010101020101, H010201010401, H010101020201, H010101010101, H010201020201, H010101010301.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED4 341
Country of registrationSwitzerland

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN4 341
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: Neither register. Assut Medical Sàrl was not found in either the U.S. or the Canadian register.

Other manufacturers in Switzerland

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