EU → US 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 1.0x1.2mm, AODI Small External Fixator 0.8x1.2mm, Acetabulum RRP/Left/for cups size 48mm or smaller, Biphasic Plate DF Right, Biphasic Plate DF Left.

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

Authorised representative in the Union: DE-AR-000005590.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED17
Country of registrationSwitzerland
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Notified body certificates

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

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