EU → North America Device Access

Ziacom Implants SLU

ES-MF-000006506 · Spain · Pinto

Ziacom Implants SLU is registered in the European database on medical devices as a manufacturer, with 1 254 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb1 238
Class IIa16

Most frequent device types declared: Z1EC, ZECI, ZFSI, ZGCC, ZICI.

Among these devices, 806 are declared sterile, 1 238 implantable, 16 reusable.

Devices declared under this manufacturer

Showing 12 of 1 254 declared devices.

Catalogue references include A2Z2015, FRUEX34TX1, GLY3413, PS150300, XST103440, ZM44011.

European nomenclature codes declared: P01020101, P01020180, P09120503, L159099,Q010399.

United States market access

FDA establishment registerRegistered with FDA
Matched entryZIACOM IMPLANTS SLU (ES) · FDA 3013547803
Devices in EUDAMED1 254
Country of registrationSpain

Device-level evidence

Devices with a numeric GTIN1 254
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. Ziacom Implants SLU is registered in the United States but was not found in the Canadian register.

Other manufacturers in Spain

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