EU → North America Device Access

41medical AG

CH-MF-000016966 · Switzerland · Bettlach

41medical AG is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb10
Class IIa5
Class I2

Most frequent device types declared: AODI Small External Fixator 0.8x1.2mm, AODI Small External Fixator 1.0x1.2mm, Acetabulum RRP/Left/for cups size 48mm or smaller, Acetabulum RRP/Right/for cups size 48mm or smaller, Biphasic Plate DF Left.

Among these devices, 12 are declared sterile, 12 implantable, 5 reusable.

Authorised representative in the Union: Axxos GmbH.

Devices declared under this manufacturer

Showing 12 of 17 declared devices.

Catalogue references include 100.002, 100.126, 100.127, 100.179, 100.205, 100.213.

European nomenclature codes declared: P09120501, H0102010299, P09120499, L26, L0920, P091299.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED17
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 GTIN17
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. 41medical AG was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
1000305600supplemented2028-02-22
1000285909supplemented2028-02-22
1000209347issued2030-02-27

Other manufacturers in Switzerland

All Switzerland manufacturers →