EU → North America Device Access

SOFTWAY MEDICAL

FR-MF-000009085 · France · FUVEAU

SOFTWAY MEDICAL is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa5

Among these devices, 5 are declared active.

Catalogue references include AE-v02, HL-v01, OM-v01, PC-v01, VE-v02.

European nomenclature codes declared: V92, Z11029092, Z11030592.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED5
Country of registrationFrance

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN2
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: Neither register. SOFTWAY MEDICAL was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
40459supplemented2031-03-18

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