EU → North America Device Access

Keri Medical SA

CH-MF-000021960 · Switzerland · Plan-les-Ouates

Keri Medical SA is registered in the European database on medical devices as a manufacturer, with 220 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa155
Class I61
Class IIb4

Most frequent device types declared: KeriFix, KeriLock.

Among these devices, 68 are declared sterile, 65 implantable, 54 reusable.

Authorised representative in the Union: Keri Medical France.

Devices declared under this manufacturer

Showing 12 of 220 declared devices.

Catalogue references include 112-A56506, 112-A56510, 112-A70200, 211-A43000, 524-A91000, EJ0101RK4CU01.

European nomenclature codes declared: L0999, P090404, L091199, L091102, L091201, P090403.

United States market access

FDA establishment registerRegistered with FDA
Matched entryKERI MEDICAL (CH) · FDA 3024706750
Devices in EUDAMED220
Country of registrationSwitzerland

Device-level evidence

Devices with a numeric GTIN220
Found in the U.S. device database91
Share41.4 %

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

Notified body certificates

CertificateStatusExpiry
286202031898issued2028-02-15
28620157857-03issued2028-02-15

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