EU → North America Device Access

BD Kiestra B.V.

NL-MF-000018863 · Netherlands · Drachten

BD Kiestra B.V. is registered in the European database on medical devices as a manufacturer, with 36 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Devices declared under this manufacturer

Showing 12 of 36 declared devices.

Catalogue references include 446097, 446098, 446231, 446942, 446946, 446971.

European nomenclature codes declared: W02039080, W02039099, W020305, W020305,W02039004, W02039004, W02039002.

United States market access

FDA establishment registerRegistered with FDA
Matched entryBD Kiestra B.V. (NL) · FDA 3010141591
Devices in EUDAMED36
Country of registrationNetherlands

Device-level evidence

Devices with a numeric GTIN36
Found in the U.S. device database18
Share50.0 %

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. BD Kiestra B.V. is registered in the United States but was not found in the Canadian register.

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