EU → North America Device Access

Corsano Health BV

NL-MF-000013825 · Netherlands · Den Haag

Corsano Health BV is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa5

Among these devices, 5 are declared active, 5 with a measuring function.

Devices declared under this manufacturer

Catalogue references include CW287-1, CW287-2, CW287-2-SBL, CW287-2-SBL-XL.

European nomenclature codes declared: Z12040113, C019004.

United States market access

FDA establishment registerRegistered with FDA
Matched entryCorsano Health SA (CH) · FDA 3038761440
Devices in EUDAMED5
Country of registrationNetherlands

Device-level evidence

Devices with a numeric GTIN5
Found in the U.S. device database1
Share20.0 %

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. Corsano Health BV is registered in the United States but was not found in the Canadian register.

Notified body certificates

CertificateStatusExpiry
20M00011CRT02issued2024-11-15

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