EU → North America Device Access

STERLAB

FR-MF-000001369 · France · vallauris

STERLAB is registered in the European database on medical devices as a manufacturer, with 60 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa60

Most frequent device types declared: 2001, 2002, 2005, 2024, AQUAVAP.

Among these devices, 3 are declared sterile, 9 active.

Devices declared under this manufacturer

Showing 12 of 60 declared devices.

Catalogue references include 2005, 2010, 2016, 2017, 2031, 28018MINI.

European nomenclature codes declared: Z12020101, S9080.

United States market access

FDA establishment registerRegistered with FDA
Matched entrySTERLAB (FR) · FDA 1000286794
Devices in EUDAMED60
Country of registrationFrance

Device-level evidence

Devices with a numeric GTIN60
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. STERLAB is registered in the United States but was not found in the Canadian register.

Other manufacturers in France

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