EU → North America Device Access

Zentech s.a.

BE-MF-000001650 · Belgium · Angleur

Zentech s.a. is registered in the European database on medical devices as a manufacturer, with 33 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Most frequent device types declared: E-GP-576, E-GQ-192, E-IX-1920, E-IY-1920, E-IZ-1920.

Catalogue references include E-GP-576, E-GQ-192, E-IX-1920, E-IZ-1920, E-KR-192, E-LC-192.

European nomenclature codes declared: W01010199, W0103010202, W01020403, W0102019007, W0102050107, W01020411.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED33
Country of registrationBelgium

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

Device-level evidence

Devices with a numeric GTIN33
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. Zentech s.a. was not found in either the U.S. or the Canadian register.

Other manufacturers in Belgium

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