EU → North America Device Access

Basko Healthcare b.v.

NL-MF-000003947 · Netherlands · Zaandam

Basko Healthcare b.v. is registered in the European database on medical devices as a manufacturer, with 795 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa795

Devices declared under this manufacturer

Showing 12 of 795 declared devices.

Catalogue references include 306EOR-XXXL, B301R-L, B309-XL, B313R-XL, BA905R-24, G301L-XL.

European nomenclature codes declared: A108006, Y061299.

United States market access

FDA establishment registerRegistered with FDA
Matched entryBASKO HEALTHCARE B.V. (NL) · FDA 3003898328
Devices in EUDAMED795
Country of registrationNetherlands

Device-level evidence

Devices with a numeric GTIN795
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. Basko Healthcare b.v. is registered in the United States but was not found in the Canadian register.

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