EU → North America Device Access

NeuroXtherapeutics SA

CH-MF-000051571 · Switzerland · Lausanne

NeuroXtherapeutics SA 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.

Authorised representative in the Union: MDSS GmbH.

Devices declared under this manufacturer

Catalogue references include CMP-01, DLP-01, MMG-01, MMIZ-01, TPR-01.

European nomenclature codes declared: Z12069092, Z12069080.

United States market access

FDA establishment registerRegistered with FDA
Matched entryNeuroXtherapeutics SA (CH) · FDA 3013517146
Devices in EUDAMED5
Country of registrationSwitzerland

Device-level evidence

Devices with a numeric GTIN5
Found in the U.S. device database3
Share60.0 %

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. NeuroXtherapeutics SA is registered in the United States but was not found in the Canadian register.

Notified body certificates

CertificateStatusExpiry
40366supplemented2029-12-19

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