EU → North America Device Access

VitalScientific B.V.

NL-MF-000021018 · Netherlands · Spankeren

VitalScientific B.V. is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Most frequent device types declared: 6002-310, 6003-404, 6003-500, 6004-301.

Devices declared under this manufacturer

Showing 12 of 16 declared devices.

Catalogue references include 6002-310, 6003-075, 6003-406, 6003-435, 6003-439, 6003-500.

European nomenclature codes declared: W0201010101, W0201010105, W02010199.

United States market access

FDA establishment registerRegistered with FDA
Matched entryVitalScientific B.V. (NL) · FDA 8030478
Devices in EUDAMED16
Country of registrationNetherlands

Device-level evidence

Devices with a numeric GTIN16
Found in the U.S. device database2
Share12.5 %

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

Other manufacturers in Netherlands

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