EU → North America Device Access

ONWARD MEDICAL N.V.

NL-MF-000022388 · Netherlands · Eindhoven

ONWARD MEDICAL N.V. is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa6

Most frequent device types declared: EXSYS01PROEU1.

Among these devices, 6 are declared active.

Devices declared under this manufacturer

Catalogue references include EXSYS01PEREU1, EXSYS01PEREU2, EXSYS01PEREU5, EXSYS01PROEU1, EXSYS01PROEU2, EXSYS01PROEU5.

European nomenclature codes declared: N010103.

United States market access

FDA establishment registerRegistered with FDA
Matched entryONWARD Medical N.V. (NL) · FDA 3034211447
Devices in EUDAMED6
Country of registrationNetherlands

Device-level evidence

Devices with a numeric GTIN6
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. ONWARD MEDICAL N.V. is registered in the United States but was not found in the Canadian register.

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